Oscillating Positive Expiratory Pressure Device

ABSTRACT

A respiratory treatment device comprising at least one chamber, a chamber inlet configured to receive air into the at least one chamber, at least one chamber outlet configured to permit air to exit the at least one chamber, and a flow path defined between the chamber inlet and the at least one chamber outlet. A restrictor member positioned in the flow path is moveable between a closed position, where a flow of air along the flow path is restricted, and an open position, where the flow of air along the flow path is less restricted. A vane in fluid communication with the flow path is operatively connected to the restrictor member and is configured to reciprocate between a first position and a second position in response to the flow of air along the flow path.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/731,861, filed on Nov. 30, 2012, pending, U.S. ProvisionalApplication No. 61/733,791, filed on Dec. 5, 2012, pending, and U.S.Provisional Application No. 61/781,533, filed on Mar. 14, 2013, pending,all of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to a respiratory treatment device, and inparticular, to an oscillating positive expiratory pressure (“OPEP”)device.

BACKGROUND

Each day, humans may produce upwards of 30 milliliters of sputum, whichis a type of bronchial secretion. Normally, an effective cough issufficient to loosen secretions and clear them from the body's airways.However, for individuals suffering from more significant bronchialobstructions, such as collapsed airways, a single cough may beinsufficient to clear the obstructions.

OPEP therapy represents an effective bronchial hygiene technique for theremoval of bronchial secretions in the human body and is an importantaspect in the treatment and continuing care of patients with bronchialobstructions, such as those suffering from chronic obstructive lungdisease. It is believed that OPEP therapy, or the oscillation ofexhalation pressure at the mouth during exhalation, effectivelytransmits an oscillating back pressure to the lungs, thereby splittingopen obstructed airways and loosening the secretions contributing tobronchial obstructions.

OPEP therapy is an attractive form of treatment because it can be easilytaught to most patients, and such patients can assume responsibility forthe administration of OPEP therapy throughout a hospitalization and alsofrom home. To that end, a number of portable OPEP devices have beendeveloped.

BRIEF SUMMARY

In one aspect, a respiratory treatment device includes a housingenclosing at least one chamber, a chamber inlet configured to receiveair into the at least one chamber, at least one chamber outletconfigured to permit air to exit the at least one chamber, and a flowpath defined between the chamber inlet and the at least one chamberoutlet. An orifice is positioned in the at least one chamber along theflow path such that the flow path passes through the orifice. A vane ispositioned adjacent the orifice and is configured to rotate in responseto the flow of air through the orifice. A peripheral portion of the vaneis angled relative to a central portion of the vane to directsubstantially all the flow of air through the orifice to a side of thevane when the central portion of the vane is substantially aligned withthe orifice. The central portion of the vane may be substantiallyplanar.

In another aspect, a restrictor member is operatively connected to thevane and is configured to rotate between a closed position, where theflow of air along the flow path is restricted, and an open position,where the flow of air along the flow path is less restricted. Therestrictor member and the vane may be operatively connected by a shaft.The restrictor member may have a center of mass offset from an axis ofrotation of the shaft. A force of gravity may bias the restrictor memberand the vane toward a position where the central portion of the vane isnot aligned with the orifice.

In another aspect, a respiratory treatment device includes a housingenclosing at least one chamber, a chamber inlet configured to receiveair into the at least one chamber, at least one chamber outletconfigured to permit air to exit the at least one chamber, and a flowpath defined between the chamber inlet and the at least one chamberoutlet. An orifice is positioned in the at least one chamber along theflow path such that the flow path passes through the orifice. A vane ispositioned adjacent the orifice and is configured to rotate in responseto the flow of air through the orifice. A peripheral portion of the vaneis configured to flex relative to a central portion of the vane inresponse to the flow of air through the orifice. The vane may besubstantially planar.

In another aspect, a flexibility of the peripheral portion of the vanemay be greater than a flexibility of the central portion of the vane.The peripheral portion of the vane and the central portion of the vanemay be separated by at least one hinge point. The at least one hingepoint may include a channel.

In another aspect, a restrictor member is operatively connected to thevane, the restrictor member being configured to rotate between a closedposition, where the flow of air along the flow path is restricted, andan open position, where the flow of air along the flow path is lessrestricted.

In another aspect, a respiratory treatment device includes a housingenclosing at least one chamber, a chamber inlet configured to receiveair into the at least one chamber, at least one chamber outletconfigured to permit air to exit the at least one chamber, and a flowpath defined between the chamber inlet and the at least one chamberoutlet. An orifice is positioned in the at least one chamber along theflow path such that the flow path passes through the orifice. A vane ispositioned adjacent the orifice and is configured to rotate in responseto the flow of air through the orifice. The vane is biased toward aposition where a central portion of the vane is not aligned with theorifice. The vane may be substantially planar.

In yet another aspect, the vane is biased by an elastic band. An end ofthe elastic band may be attached to a side of the vane opposite the sideof the vane adjacent the orifice.

In another aspect, a restrictor member is operatively connected to thevane, the restrictor member being configured to rotate between a closedposition, where the flow of air along the flow path is restricted, andan open position, where the flow of air along the flow path is lessrestricted. The restrictor member and the vane may be operativelyconnected by a shaft. The restrictor member may have a center of massoffset from an axis of rotation of the shaft. A force of gravity maybias the restrictor member and the vane toward the position where thecentral portion of the vane is not aligned with the orifice.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of an OPEP device;

FIG. 2 is a rear perspective view of the OPEP device of FIG. 1;

FIG. 3 is a cross-sectional perspective view taken along line III inFIG. 1 of the OPEP device shown without the internal components of theOPEP device;

FIG. 4 is an exploded view of the OPEP device of FIG. 1, shown with theinternal components of the OPEP device;

FIG. 5 is a cross-sectional perspective view taken along line III inFIG. 1 of the OPEP device shown with the internal components of the OPEPdevice;

FIG. 6 is a different cross-sectional perspective view taken along lineVI in FIG. 1 of the OPEP device shown with the internal components ofthe OPEP device;

FIG. 7 is a different cross-sectional perspective view taken along lineVII in FIG. 1 of the OPEP device shown with the internal components ofthe OPEP device;

FIG. 8 is a front perspective view of a restrictor member operativelyconnected to a vane;

FIG. 9 is a rear perspective view of the restrictor member operativelyconnected to the vane shown in FIG. 8;

FIG. 10 is a front view of the restrictor member operatively connectedto the vane shown in FIG. 8;

FIG. 11 is a top view of the restrictor member operatively connected tothe vane shown in FIG. 8;

FIG. 12 is a front perspective view of a variable nozzle shown withoutthe flow of exhaled air therethrough;

FIG. 13 is a rear perspective view of the variable nozzle of FIG. 12shown without the flow of exhaled air therethrough;

FIG. 14 is a front perspective view of the variable nozzle of FIG. 12shown with a high flow of exhaled air therethrough;

FIGS. 15A-C are top phantom views of the OPEP device of FIG. 1 showingan exemplary illustration of the operation of the OPEP device of FIG. 1;

FIG. 16 is a front perspective view of a different embodiment of avariable nozzle shown without the flow of exhaled air therethrough;

FIG. 17 is a rear perspective view of the variable nozzle of FIG. 16shown without the flow of exhaled air therethrough;

FIG. 18 is a front perspective view of a second embodiment of an OPEPdevice;

FIG. 19 is a rear perspective view of the OPEP device of FIG. 18;

FIG. 20 is an exploded view of the OPEP device of FIG. 18, shown withthe internal components of the OPEP device;

FIG. 21 is a cross-sectional view taken along line I in FIG. 18 of theOPEP device, shown with the internal components of the OPEP device;

FIG. 22 is a cross-sectional view taken along line II in FIG. 18 of theOPEP device, shown with the internal components of the OPEP device;

FIG. 23 is a cross-sectional view taken along line III in FIG. 18 of theOPEP device, shown with the internal components of the OPEP device;

FIG. 24 is a front perspective view of an adjustment mechanism of theOPEP device of FIG. 18;

FIG. 25 is a rear perspective view of the adjustment mechanism of FIG.24;

FIG. 26 is a front perspective view of a restrictor member operativelyconnected to a vane for use in the OPEP device of FIG. 18;

FIG. 27 is a front perspective view of the adjustment mechanism of FIG.24 assembled with the restrictor member and the vane of FIG. 26;

FIG. 28 is a partial cross-sectional view of the assembly of FIG. 27within the OPEP device of FIG. 18;

FIGS. 29A-B are partial cross-sectional views illustrating installationof the assembly of FIG. 27 within the OPEP device of FIG. 18;

FIG. 30 is a front view of the OPEP device of FIG. 18 illustrating anaspect of the adjustability of the OPEP device;

FIG. 31 is a partial cross-sectional view of the assembly of FIG. 27within the OPEP device of FIG. 18;

FIGS. 32A-B are partial cross-sectional views taken along line III inFIG. 18 of the OPEP device, illustrating possible configurations of theOPEP device;

FIGS. 33A-B are top phantom views illustrating the adjustability of theOPEP device of FIG. 18;

FIGS. 34A-B are top phantom views of the OPEP device of FIG. 18,illustrating the adjustability of the OPEP device;

FIG. 35 is a front perspective view of another embodiment of an OPEPdevice;

FIG. 36 is a rear perspective view of the OPEP device of FIG. 35;

FIG. 37 is a perspective view of the bottom of the OPEP device of FIG.35;

FIG. 38 is an exploded view of the OPEP device of FIG. 35;

FIG. 39 is a cross-sectional view taken along line I in FIG. 35, shownwithout the internal components of the OPEP device;

FIG. 40 is a cross-sectional view taken along line I in FIG. 35, shownwith the internal components of the OPEP device;

FIG. 41 is a front-perspective view of an inner casing of the OPEPdevice of FIG. 35;

FIG. 42 is a cross-sectional view of the inner casing taken along line Iof in FIG. 41;

FIG. 43 is a perspective view of a vane of the OPEP device of FIG. 35;

FIG. 44 is a front perspective view of a restrictor member of the OPEPdevice of FIG. 35;

FIG. 45 is a rear perspective view of the restrictor member of the FIG.44;

FIG. 46 is a front view of the restrictor member of FIG. 44;

FIG. 47 is a front perspective view of an adjustment mechanism of theOPEP device of FIG. 35;

FIG. 48 is a rear perspective view of the adjustment mechanism of FIG.47;

FIG. 49 is a front perspective view of the adjustment mechanism of FIGS.47-48 assembled with the restrictor member of FIGS. 44-46 and the vaneof FIG. 43;

FIG. 50 is a front perspective view of a variable nozzle of the OPEPdevice of FIG. 35;

FIG. 51 is a rear perspective view of the variable nozzle of FIG. 50;

FIG. 52 is a front perspective view of the one-way valve of the OPEPdevice of FIG. 35.

FIG. 53 is a perspective view of another embodiment of a respiratorytreatment device;

FIG. 54 is an exploded view of the respiratory treatment device of FIG.53;

FIG. 55 is a cross-sectional perspective view taken along line I in FIG.53 of the respiratory treatment device shown with the internalcomponents of the device;

FIG. 56 is a cross-sectional perspective view taken along line II inFIG. 53 of the respiratory treatment device shown with the internalcomponents of the device;

FIG. 57 is a different cross-sectional perspective view taken along lineI in FIG. 53 of the respiratory treatment device, showing a portion ofan exemplary exhalation flow path;

FIG. 58 is a different cross-sectional perspective view taken along lineII in FIG. 53, showing a portion of an exemplary exhalation flow path;

FIG. 59 is another cross-sectional perspective view taken along line Iin FIG. 53, showing a portion of an exemplary inhalation flow path;

FIG. 60 is another cross-sectional perspective view taken along line IIin FIG. 53, showing a portion of an exemplary inhalation flow path;

FIG. 61 is a front perspective view of another embodiment of arespiratory treatment device;

FIG. 62 is a rear perspective view of the respiratory treatment deviceof FIG. 61;

FIG. 63A-B are front and rear perspective views of the respiratorytreatment device of FIG. 61, showing openings formed in the device'shousing;

FIG. 64A-C are front views of the respiratory treatment device of FIG.61, illustrating the positioning of a switch relative to the openings toselectively control administration of OPEP therapy upon exhalation,inhalation, or both exhalation and inhalation;

FIG. 65 is a cross-sectional view taken along line I of the respiratorytreatment device of FIG. 62;

FIG. 66 is a cross-sectional view taken along line II of the respiratorytreatment device of FIG. 62;

FIG. 67 is a front perspective view of another embodiment of anrespiratory treatment device, configured for delivery of pressurethreshold therapy in series with OPEP therapy;

FIG. 68 is a cross-sectional view taken along line I of the respiratorytreatment device of FIG. 67;

FIG. 69 is a another cross-sectional view taken on along line I of therespiratory treatment device of FIG. 67;

FIG. 70 is a cross-sectional view taken along line II of the respiratorytreatment device of FIG. 67;

FIG. 71 is a front perspective view of another embodiment of anrespiratory treatment device, configured for delivery of pressurethreshold therapy in parallel with OPEP therapy;

FIG. 72 is a cross-sectional view taken along line I of the respiratorytreatment device of FIG. 71;

FIG. 73 is another cross-sectional view taken along line I of therespiratory treatment device of FIG. 71;

FIG. 74 is a cross-sectional view taken along line II of the respiratorytreatment device of FIG. 71;

FIG. 75 is a cross-sectional view taken along line III of therespiratory treatment device of FIG. 71;

FIG. 76 is an exemplary illustration of the net torque about therestrictor member and the vane of the OPEP device of FIG. 35 as therestrictor member rotates from a closed position to an open positionduring a period of exhalation;

FIGS. 77A-D are cross-sectional views of the OPEP device of FIG. 35illustrating the position of the restrictor member and the vane atvarious positions as the restrictor member rotates from a closedposition to an open position during a period of exhalation;

FIGS. 78A-H are various views illustrating the torques applied to therestrictor member and the vane of the OPEP device of FIG. 35 during aperiod of exhalation, and modifications thereto;

FIGS. 79A-B are top views illustrating the torque applied to therestrictor member of the OPEP device of FIG. 35, and modificationsthereto;

FIGS. 80A-B are top views illustrating the torques applied to therestrictor member and the vane of the OPEP device of FIG. 35 during aperiod of exhalation, and modifications thereto;

FIG. 81 is a top view of another modified restrictor member;

FIGS. 82A-C are cross-sectional views of the OPEP device of FIG. 35showing a biasing member connected to the vane;

FIGS. 83A-B are partial cross-sectional views of the OPEP device of FIG.35, modified to include a shuttle valve;

FIGS. 84A-84B are partial cross-sectional views of the OPEP device ofFIG. 35, showing the net torques about the restrictor member with andwithout a diverter;

FIGS. 85A-C are cross-sectional views of the OPEP device of FIG. 35,adapted to rotate the restrictor member and the vane during a period ofinhalation; and,

FIGS. 86A-C are partial top views of a modified vane.

DETAILED DESCRIPTION

OPEP therapy is effective within a range of operating conditions. Forexample, an adult human may have an exhalation flow rate ranging from 10to 60 liters per minute, and may maintain a static exhalation pressurein the range of 8 to 18 cm H₂O. Within these parameters, OPEP therapy isbelieved to be most effective when changes in the exhalation pressure(i.e., the amplitude) range from 5 to 20 cm H₂O oscillating at afrequency of 10 to 40 Hz. In contrast, an adolescent may have a muchlower exhalation flow rate, and may maintain a lower static exhalationpressure, thereby altering the operating conditions most effective forthe administration of OPEP therapy. Likewise, the ideal operatingconditions for someone suffering from a respiratory illness, or incontrast, a healthy athlete, may differ from those of an average adult.As described below, the components of the disclosed OPEP devices areselectable and/or adjustable so that ideal operating conditions (e.g.,amplitude and frequency of oscillating pressure) may be identified andmaintained. Each of the various embodiments described herein achievefrequency and amplitude ranges that fall within the desired ranges setforth above. Each of the various embodiments described herein may alsobe configured to achieve frequencies and amplitudes that fall outsidethe ranges set forth above.

First Embodiment

Referring first to FIGS. 1-4, a front perspective view, a rearperspective view, a cross-sectional front perspective view, and anexploded view of an OPEP device 100 are shown. For purposes ofillustration, the internal components of the OPEP device 100 are omittedin FIG. 3. The OPEP device 100 generally comprises a housing 102, achamber inlet 104, a first chamber outlet 106, a second chamber outlet108 (best seen in FIGS. 2 and 7), and a mouthpiece 109 in fluidcommunication with the chamber inlet 104. While the mouthpiece 109 isshown in FIGS. 1-4 as being integrally formed with the housing 102, itis envisioned that the mouthpiece 109 may be removable and replaceablewith a mouthpiece 109 of a different size or shape, as required tomaintain ideal operating conditions. In general, the housing 102 and themouthpiece 109 may be constructed of any durable material, such as apolymer. One such material is Polypropylene. Alternatively,acrylonitrile butadiene styrene (ABS) may be used.

Alternatively, other or additional interfaces, such as breathing tubesor gas masks (not shown) may be attached in fluid communication with themouthpiece 109 and/or associated with the housing 102. For example, thehousing 102 may include an inhalation port (not shown) having a separateone-way inhalation valve (not shown) in fluid communication with themouthpiece 109 to permit a user of the OPEP device 100 both to inhalethe surrounding air through the one-way valve, and to exhale through thechamber inlet 104 without withdrawing the mouthpiece 109 of the OPEPdevice 100 between periods of inhalation and exhalation. In addition,any number of aerosol delivery devices may be connected to the OPEPdevice 100, for example, through the inhalation port mentioned above,for the simultaneous administration of aerosol and OPEP therapies. Assuch, the inhalation port may include, for example, an elastomericadapter, or other flexible adapter, capable of accommodating thedifferent mouthpieces or outlets of the particular aerosol deliverydevice that a user intends to use with the OPEP device 100. As usedherein, the term aerosol delivery devices should be understood toinclude, for example, without limitation, any nebulizer, soft mistinhaler, pressurized metered dose inhaler, dry powder inhaler,combination of a holding chamber a pressurized metered dose inhaler, orthe like. Suitable commercially available aerosol delivery devicesinclude, without limitation, the AEROECLIPSE nebulizer, RESPIMAT softmist inhaler, LC Sprint nebulizer, AEROCHAMBER PLUS holding chambers,MICRO MIST nebulizer, SIDESTREAM nebulizers, Inspiration Elitenebulizers, FLOVENT pMDI, VENTOLIN pMDI, AZMACORT pMDI, BECLOVENT pMDI,QVAR pMDI and AEROBID PMDI, XOPENEX pMDI, PROAIR pMDI, PROVENT pMDI,SYMBICORT pMDI, TURBOHALER DPI, and DISKHALER DPI. Descriptions ofsuitable aerosol delivery devices may be found in U.S. Pat. Nos.4,566,452; 5,012,803; 5,012,804; 5,312,046; 5,497,944; 5,622,162;5,823,179; 6,293,279; 6,435,177; 6,484,717; 6,848,443; 7,360,537;7,568,480; and, 7,905,228, the entireties of which are hereinincorporated by reference.

In FIGS. 1-4, the housing 102 is generally box-shaped. However, ahousing 102 of any shape may be used. Furthermore, the chamber inlet104, the first chamber outlet 106, and the second chamber outlet 108could be any shape or series of shapes, such as a plurality (i.e., morethan one) of circular passages or linear slots. More importantly, itshould be appreciated that the cross-sectional area of the chamber inlet104, the first chamber outlet 106, and the second chamber outlet 108 areonly a few of the factors influencing the ideal operating conditionsdescribed above.

Preferably, the housing 102 is openable so that the components containedtherein can be periodically accessed, cleaned, replaced, orreconfigured, as required to maintain the ideal operating conditions. Assuch, the housing 102 is shown in FIGS. 1-4 as comprising a frontsection 101, a middle section 103, and a rear section 105. The frontsection 101, the middle section 103, and the rear section 105 may beremovably connected to one another by any suitable means, such as asnap-fit, a compression fit, etc., such that a seal forms between therelative sections sufficient to permit the OPEP device 100 to properlyadminister OPEP therapy.

As shown in FIG. 3, an exhalation flow path 110, identified by a dashedline, is defined between the mouthpiece 109 and at least one of thefirst chamber outlet 106 and the second chamber outlet 108 (best seen inFIG. 7). More specifically, the exhalation flow path 110 begins at themouthpiece 109, passes through the chamber inlet 104, and enters into afirst chamber 114, or an entry chamber. In the first chamber 114, theexhalation flow path makes a 180-degree turn, passes through a chamberpassage 116, and enters into a second chamber 118, or an exit chamber.In the second chamber 118, the exhalation flow path 110 may exit theOPEP device 100 through at least one of the first chamber outlet 106 andthe second chamber outlet 108. In this way, the exhalation flow path 110is “folded” upon itself, i.e., it reverses longitudinal directionsbetween the chamber inlet 104 and one of the first chamber outlet 106 orthe second chamber outlet 108. However, those skilled in the art willappreciate that the exhalation flow path 110 identified by the dashedline is exemplary, and that air exhaled into the OPEP device 100 mayflow in any number of directions or paths as it traverses from themouthpiece 109 or chamber inlet 104 and the first chamber outlet 106 orthe second chamber outlet 108.

FIG. 3 also shows various other features of the OPEP device 100associated with the housing 102. For example, a stop 122 prevents arestrictor member 130 (see FIG. 5), described below, from opening in awrong direction; a seat 124 shaped to accommodate the restrictor member130 is formed about the chamber inlet 104; and, an upper bearing 126 anda lower bearing 128 are formed within the housing 102 and configured toaccommodate a shaft rotatably mounted therebetween. One or more guidewalls 120 are positioned in the second chamber 118 to direct exhaled airalong the exhalation flow path 110.

Turning to FIGS. 5-7, various cross-sectional perspective views of theOPEP device 100 are shown with its internal components. The internalcomponents of the OPEP device 100 comprise a restrictor member 130, avane 132, and an optional variable nozzle 136. As shown, the restrictormember 130 and the vane 132 are operatively connected by means of ashaft 134 rotatably mounted between the upper bearing 126 and the lowerbearing 128, such that the restrictor member 130 and the vane 132 arerotatable in unison about the shaft 134. As described below in furtherdetail, the variable nozzle 136 includes an orifice 138 configured toincrease in size in response to the flow of exhaled air therethrough.

FIGS. 4-6 further illustrate the division of the first chamber 114 andthe second chamber 118 within the housing 102. As previously described,the chamber inlet 104 defines an entrance to the first chamber 114. Therestrictor member 130 is positioned in the first chamber 114 relative toa seat 124 about the chamber inlet 104 such that it is moveable betweena closed position, where a flow of exhaled air along the exhalation flowpath 110 through the chamber inlet 104 is restricted, and an openposition, where the flow of exhaled air through the chamber inlet 104 isless restricted. Likewise, the variable nozzle 136, which is optional,is mounted about or positioned in the chamber passage 116, such that theflow of exhaled air entering the first chamber 114 exits the firstchamber 114 through the orifice 138 of the variable nozzle 136. Exhaledair exiting the first chamber 114 through the orifice 138 of thevariable nozzle 136 enters the second chamber, which is defined by thespace within the housing 102 occupied by the vane 132 and the guidewalls 120. Depending on the position of the vane 132, the exhaled air isthen able to exit the second chamber 118 through at least one of thefirst chamber outlet 106 and the second chamber outlet 108.

FIGS. 8-14 show the internal components of the OPEP device 100 ingreater detail. Turning first to FIGS. 8-9, a front perspective view anda rear perspective view shows the restrictor member 130 operativelyconnected to the vane 132 by the shaft 134. As such, the restrictormember 130 and the vane 132 are rotatable about the shaft 134 such thatrotation of the restrictor member 130 results in a correspondingrotation of the vane 132, and vice-versa. Like the housing 102, therestrictor member 130 and the vane 132 may be made of constructed of anydurable material, such as a polymer. Preferably, they are constructed ofa low shrink, low friction plastic. One such material is acetal.

As shown, the restrictor member 130, the vane 132, and the shaft 134 areformed as a unitary component. The restrictor member 130 is generallydisk-shaped, and the vane 132 is planar. The restrictor member 130includes a generally circular face 140 axially offset from the shaft 134and a beveled or chamfered edge 142 shaped to engage the seat 124 formedabout the chamber inlet 104. In this way, the restrictor member 130 isadapted to move relative to the chamber inlet 104 about an axis ofrotation defined by the shaft 134 such that the restrictor member 130may engage the seat 124 in a closed position to substantially seal andrestrict the flow of exhaled air through the chamber inlet 104. However,it is envisioned that the restrictor member 130 and the vane 132 may beformed as separate components connectable by any suitable means suchthat they remain independently replaceable with a restrictor member 130or a vane 132 of a different shape, size, or weight, as selected tomaintain ideal operating conditions. For example, the restrictor member130 and/or the vane 132 may include one or more contoured surfaces.Alternatively, the restrictor member 130 may be configured as abutterfly valve.

Turning to FIG. 10, a front view of the restrictor member 130 and thevane 132 is shown. As previously described, the restrictor member 130comprises a generally circular face 140 axially offset from the shaft134. The restrictor member 130 further comprises a second offsetdesigned to facilitate movement of the restrictor member 130 between aclosed position and an open position. More specifically, a center 144 ofthe face 140 of the restrictor member 130 is offset from the planedefined by the radial offset and the shaft 134, or the axis of rotation.In other words, a greater surface area of the face 140 of the restrictormember 130 is positioned on one side of the shaft 134 than on the otherside of the shaft 134. Pressure at the chamber inlet 104 derived fromexhaled air produces a force acting on the face 140 of the restrictormember 130. Because the center 144 of the face 140 of the restrictormember 130 is offset as described above, a resulting force differentialcreates a torque about the shaft 134. As further explained below, thistorque facilitates movement of the restrictor member 130 between aclosed position and an open position.

Turning to FIG. 11, a top view of the restrictor member 130 and the vane132 is shown. As illustrated, the vane 132 is connected to the shaft 134at a 75° angle relative to the face 140 of restrictor member 130.Preferably, the angle will remain between 60° and 80°, although it isenvisioned that the angle of the vane 132 may be selectively adjusted tomaintain the ideal operating conditions, as previously discussed. It isalso preferable that the vane 132 and the restrictor member 130 areconfigured such that when the OPEP device 100 is fully assembled, theangle between a centerline of the variable nozzle 136 and the vane 132is between 10° and 25° when the restrictor member 130 is in a closedposition. Moreover, regardless of the configuration, it is preferablethat the combination of the restrictor member 130 and the vane 132 havea center of gravity aligned with the shaft 134, or the axis of rotation.In full view of the present disclosure, it should be apparent to thoseskilled in the art that the angle of the vane 132 may be limited by thesize or shape of the housing 102, and will generally be less than halfthe total rotation of the vane 132 and the restrictor member 130.

Turning to FIGS. 12 and 13, a front perspective view and a rearperspective view of the variable nozzle 136 is shown without the flow ofexhaled air therethrough. In general, the variable nozzle 136 includestop and bottom walls 146, side walls 148, and V-shaped slits 150 formedtherebetween. As shown, the variable nozzle is generally shaped like aduck-bill type valve. However, it should be appreciated that nozzles orvalves of other shapes and sizes may also be used. The variable nozzle136 may also include a lip 152 configured to mount the variable nozzle136 within the housing 102 between the first chamber 114 and the secondchamber 118. The variable nozzle 136 may be constructed or molded of anymaterial having a suitable flexibility, such as silicone, and preferablywith a wall thickness of between 0.50 and 2.00 millimeters, and anorifice width between 0.25 to 1.00 millimeters, or smaller depending onmanufacturing capabilities.

As previously described, the variable nozzle 136 is optional in theoperation of the OPEP device 100. It should also be appreciated that theOPEP device 100 could alternatively omit both the chamber passage 116and the variable nozzle 136, and thus comprise a single-chamberembodiment. Although functional without the variable nozzle 136, theperformance of the OPEP device 100 over a wider range of exhalation flowrates is improved when the OPEP device 100 is operated with the variablenozzle 136. The chamber passage 116, when used without the variablenozzle 136, or the orifice 138 of the variable nozzle 136, when thevariable nozzle 136 is included, serves to create a jet of exhaled airhaving an increased velocity. As explained in more detail below, theincreased velocity of the exhaled air entering the second chamber 118results in a proportional increase in the force applied by the exhaledair to the vane 132, and in turn, an increased torque about the shaft134, all of which affect the ideal operating conditions.

Without the variable nozzle 136, the orifice between the first chamber114 and the second chamber 118 is fixed according to the size, shape,and cross-sectional area of the chamber passage 116, which may beselectively adjusted by any suitable means, such as replacement of themiddle section 103 or the rear section 105 of the housing. On the otherhand, when the variable nozzle 136 is included in the OPEP device 100,the orifice between the first chamber 114 and the second chamber 118 isdefined by the size, shape, and cross-sectional area of the orifice 138of the variable nozzle 136, which may vary according to the flow rate ofexhaled air and/or the pressure in the first chamber 114.

Turning to FIG. 14, a front perspective view of the variable nozzle 136is shown with a flow of exhaled air therethrough. One aspect of thevariable nozzle 136 shown in FIG. 14 is that, as the orifice 138 opensin response to the flow of exhaled air therethrough, the cross-sectionalshape of the orifice 138 remains generally rectangular, which during theadministration of OPEP therapy results in a lower drop in pressurethrough the variable nozzle 136 from the first chamber 114 (See FIGS. 3and 5) to the second chamber 118. The generally consistent rectangularshape of the orifice 138 of the variable nozzle 136 during increasedflow rates is achieved by the V-shaped slits 150 formed between the topand bottom walls 146 and the side walls 148, which serve to permit theside walls 148 to flex without restriction. Preferably, the V-shapedslits 150 are as thin as possible to minimize the leakage of exhaled airtherethrough. For example, the V-shaped slits 150 may be approximately0.25 millimeters wide, but depending on manufacturing capabilities,could range between 0.10 and 0.50 millimeters. Exhaled air that doesleak through the V-shaped slits 150 is ultimately directed along theexhalation flow path by the guide walls 120 in the second chamber 118protruding from the housing 102.

It should be appreciated that numerous factors contribute to the impactthe variable nozzle 136 has on the performance of the OPEP device 100,including the geometry and material of the variable nozzle 136. By wayof example only, in order to attain a target oscillating pressurefrequency of between 10 to 13 Hz at an exhalation flow rate of 15 litersper minute, in one embodiment, a 1.0 by 20.0 millimeter passage ororifice may be utilized. However, as the exhalation flow rate increases,the frequency of the oscillating pressure in that embodiment alsoincreases, though at a rate too quickly in comparison to the targetfrequency. In order to attain a target oscillating pressure frequency ofbetween 18 to 20 Hz at an exhalation flow rate of 45 liters per minute,the same embodiment may utilize a 3.0 by 20.0 millimeter passage ororifice. Such a relationship demonstrates the desirability of a passageor orifice that expands in cross-sectional area as the exhalation flowrate increases in order to limit the drop in pressure across thevariable nozzle 136.

Turning to FIGS. 15A-C, top phantom views of the OPEP device 100 show anexemplary illustration of the operation of the OPEP device 100.Specifically, FIG. 15A shows the restrictor member 130 in an initial, orclosed position, where the flow of exhaled air through the chamber inlet104 is restricted, and the vane 132 is in a first position, directingthe flow of exhaled air toward the first chamber outlet 106. FIG. 15Bshows this restrictor member 130 in a partially open position, where theflow of exhaled air through the chamber inlet 104 is less restricted,and the vane 132 is directly aligned with the jet of exhaled air exitingthe variable nozzle 136. FIG. 15C shows the restrictor member 130 in anopen position, where the flow of exhaled air through the chamber inlet104 is even less restricted, and the vane 132 is in a second position,directing the flow of exhaled air toward the second chamber outlet 108.It should be appreciated that the cycle described below is merelyexemplary of the operation of the OPEP device 100, and that numerousfactors may affect operation of the OPEP device 100 in a manner thatresults in a deviation from the described cycle. However, during theoperation of the OPEP device 100, the restrictor member 130 and the vane132 will generally reciprocate between the positions shown in FIGS. 15Aand 15C.

During the administration of OPEP therapy, the restrictor member 130 andthe vane 132 may be initially positioned as shown in FIG. 15A. In thisposition, the restrictor member 130 is in a closed position, where theflow of exhaled air along the exhalation path through the chamber inlet104 is substantially restricted. As such, an exhalation pressure at thechamber inlet 104 begins to increase when a user exhales into themouthpiece 108. As the exhalation pressure at the chamber inlet 104increases, a corresponding force acting on the face 140 of therestrictor member 130 increases. As previously explained, because thecenter 144 of the face 140 is offset from the plane defined by theradial offset and the shaft 134, a resulting net force creates anegative or opening torque about the shaft. In turn, the opening torquebiases the restrictor member 130 to rotate open, letting exhaled airenter the first chamber 114, and biases the vane 132 away from its firstposition. As the restrictor member 130 opens and exhaled air is let intothe first chamber 114, the pressure at the chamber inlet 104 begins todecrease, the force acting on the face 140 of the restrictor memberbegins to decrease, and the torque biasing the restrictor member 130open begins to decrease.

As exhaled air continues to enter the first chamber 114 through thechamber inlet 104, it is directed along the exhalation flow path 110 bythe housing 102 until it reaches the chamber passage 116 disposedbetween the first chamber 114 and the second chamber 118. If the OPEPdevice 100 is being operated without the variable nozzle 136, theexhaled air accelerates through the chamber passage 116 due to thedecrease in cross-sectional area to form a jet of exhaled air. Likewise,if the OPEP device 100 is being operated with the variable nozzle 136,the exhaled air accelerates through the orifice 138 of the variablenozzle 136, where the pressure through the orifice 138 causes the sidewalls 148 of the variable nozzle 136 to flex outward, thereby increasingthe size of the orifice 138, as well as the resulting flow of exhaledair therethrough. To the extent some exhaled air leaks out of theV-shaped slits 150 of the variable nozzle 136, it is directed backtoward the jet of exhaled air and along the exhalation flow path by theguide walls 120 protruding into the housing 102.

Then, as the exhaled air exits the first chamber 114 through thevariable nozzle 136 and/or chamber passage 116 and enters the secondchamber 118, it is directed by the vane 132 toward the front section 101of the housing 102, where it is forced to reverse directions beforeexiting the OPEP device 100 through the open first chamber exit 106. Asa result of the change in direction of the exhaled air toward the frontsection 101 of the housing 102, a pressure accumulates in the secondchamber 118 near the front section 101 of the housing 102, therebyresulting in a force on the adjacent vane 132, and creating anadditional negative or opening torque about the shaft 134. The combinedopening torques created about the shaft 134 from the forces acting onthe face 140 of the restrictor member 130 and the vane 132 cause therestrictor member 130 and the vane 132 to rotate about the shaft 134from the position shown in FIG. 15A toward the position shown in FIG.15B.

When the restrictor member 130 and the vane 132 rotate to the positionshown in FIG. 15B, the vane 132 crosses the jet of exhaled air exitingthe variable nozzle 136 or the chamber passage 116. Initially, the jetof exhaled air exiting the variable nozzle 136 or chamber passage 116provides a force on the vane 132 that, along with the momentum of thevane 132, the shaft 134, and the restrictor member 130, propels the vane132 and the restrictor member 130 to the position shown in FIG. 15C.However, around the position shown in FIG. 15B, the force acting on thevane 132 from the exhaled air exiting the variable nozzle 136 alsoswitches from a negative or opening torque to a positive or closingtorque. More specifically, as the exhaled air exits the first chamber114 through the variable nozzle 136 and enters the second chamber 118,it is directed by the vane 132 toward the front section 101 of thehousing 102, where it is forced to reverse directions before exiting theOPEP device 100 through the open second chamber exit 108. As a result ofthe change in direction of the exhaled air toward the front section 101of the housing 102, a pressure accumulates in the second chamber 118near the front section 101 of the housing 102, thereby resulting in aforce on the adjacent vane 132, and creating a positive or closingtorque about the shaft 134. As the vane 132 and the restrictor member130 continue to move closer to the position shown in FIG. 15C, thepressure accumulating in the section chamber 118 near the front section101 of the housing 102, and in turn, the positive or closing torqueabout the shaft 134, continues to increase, as the flow of exhaled airalong the exhalation flow path 110 and through the chamber inlet 104 iseven less restricted. Meanwhile, although the torque about the shaft 134from the force acting on the restrictor member 130 also switches from anegative or opening torque to a positive or closing torque around theposition shown in FIG. 15B, its magnitude is essentially negligible asthe restrictor member 130 and the vane 132 rotate from the positionshown in FIG. 15B to the position shown in FIG. 15C.

After reaching the position shown in FIG. 15C, and due to the increasedpositive or closing torque about the shaft 134, the vane 132 and therestrictor member 130 reverse directions and begin to rotate back towardthe position shown in FIG. 15B. As the vane 132 and the restrictormember 130 approach the position shown in FIG. 15B, and the flow ofexhaled through the chamber inlet 104 is increasingly restricted, thepositive or closing torque about the shaft 134 begins to decrease. Whenthe restrictor member 130 and the vane 132 reach the position 130 shownin FIG. 15B, the vane 132 crosses the jet of exhaled air exiting thevariable nozzle 136 or the chamber passage 116, thereby creating a forceon the vane 132 that, along with the momentum of the vane 132, the shaft134, and the restrictor member 130, propels the vane 132 and therestrictor member 130 back to the position shown in FIG. 15A. After therestrictor member 130 and the vane 132 return to the position shown inFIG. 15A, the flow of exhaled air through the chamber inlet 104 isrestricted, and the cycle described above repeats itself.

It should be appreciated that, during a single period of exhalation, thecycle described above will repeat numerous times. Thus, by repeatedlymoving the restrictor member 130 between a closed position, where theflow of exhaled air through the chamber inlet 104 is restricted, and anopen position, where the flow of exhaled air through the chamber inlet104 is less restricted, an oscillating back pressure is transmitted tothe user of the OPEP device 100 and OPEP therapy is administered.

Turning now to FIGS. 16-17, an alternative embodiment of a variablenozzle 236 is shown. The variable nozzle 236 may be used in the OPEPdevice 100 as an alternative to the variable nozzle 136 described above.As shown in FIGS. 16-17, the variable nozzle 236 includes an orifice238, top and bottom walls 246, side walls 248, and a lip 252 configuredto mount the variable nozzle 236 within the housing of the OPEP device100 between the first chamber 114 and the second chamber 118 in the samemanner as the variable nozzle 136. Similar to the variable nozzle 136shown in FIGS. 12-13, the variable nozzle 236 may be constructed ormolded of any material having a suitable flexibility, such as silicone.

During the administration of OPEP therapy, as the orifice 238 of thevariable nozzle 236 opens in response to the flow of exhaled airtherethrough, the cross-sectional shape of the orifice 238 remainsgenerally rectangular, which results in a lower drop in pressure throughthe variable nozzle 236 from the first chamber 114 to the second chamber118. The generally consistent rectangular shape of the orifice 238 ofthe variable nozzle 236 during increased flow rates is achieved by thin,creased walls formed in the top and bottom walls 246, which allow theside walls 248 to flex easier and with less resistance. A furtheradvantage of this embodiment is that there is no leakage out of the topand bottom walls 246 while exhaled air flows through the orifice 238 ofthe variable nozzle 236, such as for example, through the V-shaped slits150 of the variable nozzle 136 shown in FIGS. 12-13.

Those skilled in the art will also appreciate that, in someapplications, only positive expiratory pressure (without oscillation)may be desired, in which case the OPEP device 100 may be operatedwithout the restrictor member 130, but with a fixed orifice or manuallyadjustable orifice instead. The positive expiratory pressure embodimentmay also comprise the variable nozzle 136, or the variable nozzle 236,in order to maintain a relatively consistent back pressure within adesired range.

Second Embodiment

Turning now to FIGS. 18-19, a front perspective view and a rearperspective view of a second embodiment of an OPEP device 200 is shown.The configuration and operation of the OPEP device 200 is similar tothat of the OPEP device 100. However, as best shown in FIGS. 20-24, theOPEP device 200 further includes an adjustment mechanism 253 adapted tochange the relative position of the chamber inlet 204 with respect tothe housing 202 and the restrictor member 230, which in turn changes therange of rotation of the vane 232 operatively connected thereto. Asexplained below, a user is therefore able to conveniently adjust boththe frequency and the amplitude of the OPEP therapy administered by theOPEP device 200 without opening the housing 202 and disassembling thecomponents of the OPEP device 200.

The OPEP device 200 generally comprises a housing 202, a chamber inlet204, a first chamber outlet 206 (best seen in FIGS. 23 and 32), a secondchamber outlet 208 (best seen in FIGS. 23 and 32), and a mouthpiece 209in fluid communication with the chamber inlet 204. As with the OPEPdevice 100, a front section 201, a middle section 203, and a rearsection 205 of the housing 202 are separable so that the componentscontained therein can be periodically accessed, cleaned, replaced, orreconfigured, as required to maintain the ideal operating conditions.The OPEP device also includes an adjustment dial 254, as describedbelow.

As discussed above in relation to the OPEP device 100, the OPEP device200 may be adapted for use with other or additional interfaces, such asan aerosol delivery device. In this regard, the OPEP device 200 isequipped with an inhalation port 211 (best seen in FIGS. 19, 21, and 23)in fluid communication with the mouthpiece 209 and the chamber inlet204. As noted above, the inhalation port may include a separate one-wayvalve (not shown) to permit a user of the OPEP device 200 both to inhalethe surrounding air through the one-way valve and to exhale through thechamber inlet 204 without withdrawing the mouthpiece 209 of the OPEPdevice 200 between periods of inhalation and exhalation. In addition,the aforementioned aerosol delivery devices may be connected to theinhalation port 211 for the simultaneous administration of aerosol andOPEP therapies.

An exploded view of the OPEP device 200 is shown in FIG. 20. In additionto the components of the housing described above, the OPEP device 200includes a restrictor member 230 operatively connected to a vane 232 bya pin 231, an adjustment mechanism 253, and a variable nozzle 236. Asshown in the cross-sectional view of FIG. 21, when the OPEP device 200is in use, the variable nozzle 236 is positioned between the middlesection 203 and the rear section 205 of the housing 202, and theadjustment mechanism 253, the restrictor member 230, and the vane 232form an assembly.

Turning to FIGS. 21-23, various cross-sectional perspective views of theOPEP device 200 are shown. As with the OPEP device 100, an exhalationflow path 210, identified by a dashed line, is defined between themouthpiece 209 and at least one of the first chamber outlet 206 and thesecond chamber outlet 208 (best seen in FIGS. 23 and 32). As a result ofa one-way valve (not-shown) and/or an aerosol delivery device (notshown) attached to the inhalation port 211, the exhalation flow path 210begins at the mouthpiece 209 and is directed toward the chamber inlet204, which in operation may or may not be blocked by the restrictormember 230. After passing through the chamber inlet 204, the exhalationflow path 210 enters a first chamber 214 and makes a 180° turn towardthe variable nozzle 236. After passing through the orifice 238 of thevariable nozzle 236, the exhalation flow path 210 enters a secondchamber 218. In the second chamber 218, the exhalation flow path 210 mayexit the OPEP device 200 through at least one of the first chamberoutlet 206 or the second chamber outlet 208. Those skilled in the artwill appreciate that the exhalation flow path 210 identified by thedashed line is exemplary, and that air exhaled into the OPEP device 200may flow in any number of directions or paths as it traverses from themouthpiece 209 or chamber inlet 204 to the first chamber outlet 206 orthe second chamber outlet 208.

Referring to FIGS. 24-25, front and rear perspective views of theadjustment mechanism 253 of the OPEP device 200 are shown. In general,the adjustment mechanism 253 includes an adjustment dial 254, a shaft255, and a frame 256. A protrusion 258 is positioned on a rear face 260of the adjustment dial, and is adapted to limit the selective rotationof the adjustment mechanism 253 by a user, as further described below.The shaft 255 includes keyed portions 262 adapted to fit within upperand lower bearings 226, 228 formed in the housing 200 (see FIGS. 21 and28-29). The shaft further includes an axial bore 264 configured toreceive the pin 231 operatively connecting the restrictor member 230 andthe vane 232. As shown, the frame 256 is spherical, and as explainedbelow, is configured to rotate relative to the housing 202, whileforming a seal between the housing 202 and the frame 256 sufficient topermit the administration of OPEP therapy. The frame 256 includes acircular opening defined by a seat 224 adapted to accommodate therestrictor member 230. In use, the circular opening functions as thechamber inlet 204. The frame 256 also includes a stop 222 for preventingthe restrictor member 230 from opening in a wrong direction.

Turning to FIG. 26, a front perspective view of the restrictor member230 and the vane 232 is shown. The design, materials, and configurationof the restrictor member 230 and the vane 232 may be the same asdescribed above in regards to the OPEP device 100. However, therestrictor member 230 and the vane 232 in the OPEP device 200 areoperatively connected by a pin 231 adapted for insertion through theaxial bore 264 in the shaft 255 of the adjustment mechanism 253. The pin231 may be constructed, for example, by stainless steel. In this way,rotation of the restrictor member 230 results in a correspondingrotation of the vane 232, and vice versa.

Turning to FIG. 27, a front perspective view of the adjustment mechanism253 assembled with the restrictor member 230 and the vane 232 is shown.In this configuration, it can be seen that the restrictor member 230 ispositioned such that it is rotatable relative to the frame 256 and theseat 224 between a closed position (as shown), where a flow of exhaledair along the exhalation flow path 210 through the chamber inlet 204 isrestricted, and an open position (not shown), where the flow of exhaledair through the chamber inlet 204 is less restricted. As previouslymentioned the vane 232 is operatively connected to the restrictor member230 by the pin 231 extending through shaft 255, and is adapted to movein unison with the restrictor member 230. It can further be seen thatthe restrictor member 230 and the vane 232 are supported by theadjustment mechanism 253, which itself is rotatable within the housing202 of the OPEP device 200, as explained below.

FIGS. 28 and 29A-B are partial cross-sectional views illustrating theadjustment mechanism 253 mounted within the housing 202 of the OPEPdevice 200. As shown in FIG. 28, the adjustment mechanism 253, as wellas the restrictor member 230 and the vane 232, are rotatably mountedwithin the housing 200 about an upper and lower bearing 226, 228, suchthat a user is able to rotate the adjustment mechanism 253 using theadjustment dial 254. FIGS. 29A-29B further illustrates the process ofmounting and locking the adjustment mechanism 253 within the lowerbearing 228 of the housing 202. More specifically, the keyed portion 262of the shaft 255 is aligned with and inserted through a rotational lock166 formed in the housing 202, as shown in FIG. 29A. Once the keyedportion 262 of the shaft 255 is inserted through the rotational lock266, the shaft 255 is rotated 90° to a locked position, but remains freeto rotate. The adjustment mechanism 253 is mounted and locked within theupper bearing 226 in the same manner.

Once the housing 200 and the internal components of the OPEP device 200are assembled, the rotation of the shaft 255 is restricted to keep itwithin a locked position in the rotational lock 166. As shown in a frontview of the OPEP device 200 in FIG. 30, two stops 268, 288 arepositioned on the housing 202 such that they engage the protrusion 258formed on the rear face 260 of the adjustment dial 254 when a userrotates the adjustment dial 254 to a predetermined position. Forpurposes of illustration, the OPEP device 200 is shown in FIG. 30without the adjustment dial 254 or the adjustment mechanism 253, whichwould extend from the housing 202 through an opening 269. In this way,rotation of the adjustment dial 254, the adjustment mechanism 253, andthe keyed portion 262 of the shaft 255 can be appropriately restricted.

Turning to FIG. 31, a partial cross-sectional view of the adjustmentmechanism 253 mounted within the housing 200 is shown. As previouslymentioned, the frame 256 of the adjustment mechanism 253 is spherical,and is configured to rotate relative to the housing 202, while forming aseal between the housing 202 and the frame 256 sufficient to permit theadministration of OPEP therapy. As shown in FIG. 31, a flexible cylinder271 extending from the housing 202 completely surrounds a portion of theframe 256 to form a sealing edge 270. Like the housing 202 and therestrictor member 230, the flexible cylinder 271 and the frame 256 maybe constructed of a low shrink, low friction plastic. One such materialis acetal. In this way, the sealing edge 270 contacts the frame 256 fora full 360° and forms a seal throughout the permissible rotation of theadjustment member 253.

The selective adjustment of the OPEP device 200 will now be describedwith reference to FIGS. 32A-B, 33A-B, and 34A-B. FIGS. 32A-B are partialcross-sectional views of the OPEP device 200; FIGS. 33A-B areillustrations of the adjustability of the OPEP device 200; and, FIGS.34A-B are top phantom views of the OPEP device 200. As previouslymentioned with regards to the OPEP device 100, it is preferable that thevane 232 and the restrictor member 230 are configured such that when theOPEP device 200 is fully assembled, the angle between a centerline ofthe variable nozzle 236 and the vane 232 is between 10° and 25° when therestrictor member 230 is in a closed position. However, it should beappreciated that the adjustability of the OPEP device 200 is not limitedto the parameters described herein, and that any number ofconfigurations may be selected for purposes of administering OPEPtherapy within the ideal operating conditions.

FIG. 32A shows the vane 232 at an angle of 10° from the centerline ofthe variable nozzle 236, whereas FIG. 32B shows the vane 232 at an angleof 25° from the centerline of the variable nozzle 236. FIG. 33Aillustrates the necessary position of the frame 256 (shown in phantom)relative to the variable nozzle 236 such that the angle between acenterline of the variable nozzle 236 and the vane 232 is 10° when therestrictor member 230 is in the closed position. FIG. 33B, on the otherhand, illustrates the necessary position of the frame 256 (shown inphantom) relative to the variable nozzle 236 such that the angle betweena centerline of the variable nozzle 236 and the vane 232 is 25° when therestrictor member 230 is in the closed position.

Referring to FIGS. 34A-B, side phantom views of the OPEP device 200 areshown. The configuration shown in FIG. 34A corresponds to theillustrations shown in FIGS. 32A and 33A, wherein the angle between acenterline of the variable nozzle 236 and the vane 232 is 10° when therestrictor member 230 is in the closed position. FIG. 34B, on the otherhand, corresponds to the illustrations shown in FIGS. 32B and 33B,wherein the angle between a centerline of the variable nozzle 236 andthe vane 232 is 25° when the restrictor member 230 is in the closedposition. In other words, the frame 256 of the adjustment member 253 hasbeen rotated counter-clockwise 15°, from the position shown in FIG. 34A,to the position shown in FIG. 34B, thereby also increasing thepermissible rotation of the vane 232.

In this way, a user is able to rotate the adjustment dial 254 toselectively adjust the orientation of the chamber inlet 204 relative tothe restrictor member 230 and the housing 202. For example, a user mayincrease the frequency and amplitude of the OPEP therapy administered bythe OPEP device 200 by rotating the adjustment dial 254, and thereforethe frame 256, toward the position shown in FIG. 34A. Alternatively, auser may decrease the frequency and amplitude of the OPEP therapyadministered by the OPEP device 200 by rotating the adjustment dial 254,and therefore the frame 256, toward the position shown in FIG. 34B.Furthermore, as shown for example in FIGS. 18 and 30, indicia may beprovided to aid the user in the setting of the appropriate configurationof the OPEP device 200.

Operating conditions similar to those described below with reference tothe OPEP device 800 may also be achievable for an OPEP device accordingto the OPEP device 200.

Third Embodiment

Turning to FIGS. 35-37, another embodiment of an OPEP device 300 isshown. The OPEP device 300 is similar to that of the OPEP device 200 inthat is selectively adjustable. As best seen in FIGS. 35, 37, 40, and49, the OPEP device 300, like the OPEP device 300, includes anadjustment mechanism 353 adapted to change the relative position of achamber inlet 304 with respect to a housing 302 and a restrictor member330, which in turn changes the range of rotation of a vane 332operatively connected thereto. As previously explained with regards tothe OPEP device 200, a user is therefore able to conveniently adjustboth the frequency and the amplitude of the OPEP therapy administered bythe OPEP device 300 without opening the housing 302 and disassemblingthe components of the OPEP device 300. The administration of OPEPtherapy using the OPEP device 300 is otherwise the same as describedabove with regards to the OPEP device 100.

The OPEP device 300 comprises a housing 302 having a front section 301,a rear section 305, and an inner casing 303. As with the previouslydescribed OPEP devices, the front section 301, the rear section 305, andthe inner casing 303 are separable so that the components containedtherein can be periodically accessed, cleaned, replaced, orreconfigured, as required to maintain the ideal operating conditions.For example, as shown in FIGS. 35-37, the front section 301 and the rearsection 305 of the housing 302 are removably connected via a snap fitengagement.

The components of the OPEP device 300 are further illustrated in theexploded view of FIG. 38. In general, in addition to the front section301, the rear section 305, and the inner casing 303, the OPEP device 300further comprises a mouthpiece 309, an inhalation port 311, a one-wayvalve 384 disposed therebetween, an adjustment mechanism 353, arestrictor member 330, a vane 332, and a variable nozzle 336.

As seen in FIGS. 39-40, the inner casing 303 is configured to fit withinthe housing 302 between the front section 301 and the rear section 305,and partially defines a first chamber 314 and a second chamber 318. Theinner casing 303 is shown in further detail in the perspective and crosssectional views shown in FIGS. 41-42. A first chamber outlet 306 and asecond chamber outlet 308 are formed within the inner casing 303. Oneend 385 of the inner casing 303 is adapted to receive the variablenozzle 336 and maintain the variable nozzle 336 between the rear section305 and the inner casing 303. An upper bearing 326 and a lower bearing328 for supporting the adjustment mechanism 353 is formed, at least inpart, within the inner casing 303. Like the flexible cylinder 271 andsealing edge 270 described above with regards to the OPEP device 200,the inner casing 303 also includes a flexible cylinder 371 with asealing edge 370 for engagement about a frame 356 of the adjustmentmechanism 353.

The vane 332 is shown in further detail in the perspective view shown inFIG. 43. A shaft 334 extends from the vane 332 and is keyed to engage acorresponding keyed portion within a bore 365 of the restrictor member330. In this way, the shaft 334 operatively connects the vane 332 withthe restrictor member 330 such that the vane 332 and the restrictormember 330 rotate in unison.

The restrictor member 330 is shown in further detail in the perspectiveviews shown in FIGS. 44-45. The restrictor member 330 includes a keyedbore 365 for receiving the shaft 334 extending from the vane 332, andfurther includes a stop 322 that limits permissible rotation of therestrictor member 330 relative to a seat 324 of the adjustment member353. As shown in the front view of FIG. 46, like the restrictor member330, the restrictor member 330 further comprises an offset designed tofacilitate movement of the restrictor member 330 between a closedposition and an open position. More specifically, a greater surface areaof the face 340 of the restrictor member 330 is positioned on one sideof the bore 365 for receiving the shaft 334 than on the other side ofthe bore 365. As described above with regards to the restrictor member130, this offset produces an opening torque about the shaft 334 duringperiods of exhalation.

The adjustment mechanism 353 is shown in further detail in the front andrear perspective views of FIGS. 47 and 48. In general, the adjustmentmechanism includes a frame 356 adapted to engage the sealing edge 370 ofthe flexible cylinder 371 formed on the inner casing 303. A circularopening in the frame 356 forms a seat 324 shaped to accommodate therestrictor member 330. In this embodiment, the seat 324 also defines thechamber inlet 304. The adjustment mechanism 353 further includes an arm354 configured to extend from the frame 356 to a position beyond thehousing 302 in order to permit a user to selectively adjust theorientation of the adjustment mechanism 353, and therefore the chamberinlet 304, when the OPEP device 300 is fully assembled. The adjustmentmechanism 353 also includes an upper bearing 385 and a lower bearing 386for receiving the shaft 334.

An assembly of the vane 332, the adjustment mechanism 353, and therestrictor member 330 is shown in the perspective view of FIG. 49. Aspreviously explained, the vane 332 and the restrictor member 330 areoperatively connected by the shaft 334 such that rotation of the vane332 results in rotation of the restrictor member 330, and vice versa. Incontrast, the adjustment mechanism 353, and therefore the seat 324defining the chamber inlet 304, is configured to rotate relative to thevane 332 and the restrictor member 330 about the shaft 334. In this way,a user is able to rotate the arm 354 to selectively adjust theorientation of the chamber inlet 304 relative to the restrictor member330 and the housing 302. For example, a user may increase the frequencyand amplitude of the OPEP therapy administered by the OPEP device 800 byrotating the arm 354, and therefore the frame 356, in a clockwisedirection. Alternatively, a user may decrease the frequency andamplitude of the OPEP therapy administered by the OPEP device 300 byrotating the adjustment arm 354, and therefore the frame 356, in acounter-clockwise direction. Furthermore, as shown for example in FIGS.35 and 37, indicia may be provided on the housing 302 to aid the user inthe setting of the appropriate configuration of the OPEP device 300.

The variable nozzle 336 is shown in further detail in the front and rearperspective views of FIGS. 50 and 51. The variable nozzle 336 in theOPEP device 300 is similar to the variable nozzle 236 described abovewith regards to the OPEP device 200, except that the variable nozzle 336also includes a base plate 387 configured to fit within one end 385 (seeFIGS. 41-42) of the inner casing 303 and maintain the variable nozzle336 between the rear section 305 and the inner casing 303. Like thevariable nozzle 236, the variable nozzle 336 and base plate 387 may bemade of silicone.

The one-way valve 384 is shown in further detail in the frontperspective view of FIG. 52. In general, the one-way valve 384 comprisesa post 388 adapted for mounting in the front section 301 of the housing302, and a flap 389 adapted to bend or pivot relative to the post 388 inresponse to a force or a pressure on the flap 389. Those skilled in theart will appreciate that other one-way valves may be used in this andother embodiments described herein without departing from the teachingsof the present disclosure. As seen in FIGS. 39-40, the one-way valve 384may be positioned in the housing 302 between the mouthpiece 309 and theinhalation port 311.

As discussed above in relation to the OPEP device 100, the OPEP device300 may be adapted for use with other or additional interfaces, such asan aerosol delivery device. In this regard, the OPEP device 300 isequipped with an inhalation port 311 (best seen in FIGS. 35-36 and38-40) in fluid communication with the mouthpiece 309. As noted above,the inhalation port may include a separate one-way valve 384 (best seenin FIGS. 39-40 and 52) configured to permit a user of the OPEP device300 both to inhale the surrounding air through the one-way valve 384 andto exhale through the chamber inlet 304, without withdrawing themouthpiece 309 of the OPEP device 300 between periods of inhalation andexhalation. In addition, the aforementioned commercially availableaerosol delivery devices may be connected to the inhalation port 311 forthe simultaneous administration of aerosol therapy (upon inhalation) andOPEP therapy (upon exhalation).

The OPEP device 300 and the components described above are furtherillustrated in the cross-sectional views shown in FIGS. 39-40. Forpurposes of illustration, the cross-sectional view of FIG. 39 is shownwithout all the internal components of the OPEP device 300.

The front section 301, the rear section 305, and the inner casing 303are assembled to form a first chamber 314 and a second chamber 318. Aswith the OPEP device 100, an exhalation flow path 310, identified by adashed line, is defined between the mouthpiece 309 and at least one ofthe first chamber outlet 306 (best seen in FIGS. 39-40 and 42) and thesecond chamber outlet 308 (best seen in FIG. 41), both of which areformed within the inner casing 303. As a result of the inhalation port311 and the one-way valve 348, the exhalation flow path 310 begins atthe mouthpiece 309 and is directed toward the chamber inlet 304, whichin operation may or may not be blocked by the restrictor member 330.After passing through the chamber inlet 304, the exhalation flow path310 enters the first chamber 314 and makes a 180° turn toward thevariable nozzle 336. After passing through an orifice 338 of thevariable nozzle 336, the exhalation flow path 310 enters the secondchamber 318. In the second chamber 318, the exhalation flow path 310 mayexit the second chamber 318, and ultimately the housing 302, through atleast one of the first chamber outlet 306 or the second chamber outlet308. Those skilled in the art will appreciate that the exhalation flowpath 310 identified by the dashed line is exemplary, and that airexhaled into the OPEP device 300 may flow in any number of directions orpaths as it traverses from the mouthpiece 309 or chamber inlet 304 tothe first chamber outlet 306 or the second chamber outlet 308. Aspreviously noted, the administration of OPEP therapy using the OPEPdevice 300 is otherwise the same as described above with regards to theOPEP device 100.

Solely by way of example, the follow operating conditions, orperformance characteristics, may be achieved by an OPEP device accordingto the OPEP device 300, with the adjustment dial 354 set for increasedfrequency and amplitude:

Flow Rate (lpm) 10 30 Frequency (Hz) 7 20 Upper Pressure (cm H2O) 13 30Lower Pressure (cm H2O) 1.5 9 Amplitude (cm H2O) 11.5 21The frequency and amplitude may decrease, for example, by approximately20% with the adjustment dial 354 set for decreased frequency andamplitude. Other frequency and amplitude targets may be achieved byvarying the particular configuration or sizing of elements, for example,increasing the length of the vane 332 results in a slower frequency,whereas, decreasing the size of the orifice 338 results in a higherfrequency. The above example is merely one possible set of operatingconditions for an OPEP device according to the embodiment describedabove.

Fourth Embodiment

Turning to FIGS. 53-56, another embodiment of a respiratory treatmentdevice 400 is shown. Unlike the previously described OPEP devices, therespiratory treatment device 400 is configured to administer oscillatingpressure therapy upon both exhalation and inhalation. Those skilled inthe art will appreciate that the concepts described below with regardsto the respiratory treatment device 400 may be applied to any of thepreviously described OPEP devices, such that oscillating pressuretherapy may be administered upon both exhalation and inhalation.Likewise, the respiratory treatment device 400 may incorporate any ofthe concepts above regarding the previously described OPEP devices,including for example, a variable nozzle, an inhalation port adapted foruse with an aerosol delivery device for the administration of aerosoltherapy, an adjustment mechanism, etc.

As shown in FIGS. 53 and 54, the respiratory treatment device 400includes a housing 402 having a front section 401, a middle section 403,and a rear section 405. As with the OPEP devices described above, thehousing 402 is openable so that the contents of the housing 402 may beaccessed for cleaning and/or selective replacement or adjustment of thecomponents contained therein to maintain ideal operating conditions. Thehousing 402 further includes a first opening 412, a second opening 413,and a third opening 415.

Although the first opening 412 is shown in FIGS. 53 and 54 inassociation with a mouthpiece 409, the first opening 412 mayalternatively be associated with other user interfaces, for example, agas mask or a breathing tube. The second opening 413 includes a one-wayexhalation valve 490 configured to permit air exhaled into the housing402 to exit the housing 402 upon exhalation at the first opening 412.The third opening 415 includes a one-way inhalation valve 484 configuredto permit air outside the housing 402 to enter the housing 402 uponinhalation at the first opening 412. As shown in greater detail in FIG.54, the respiratory treatment device 400 further includes a manifoldplate 493 having an exhalation passage 494 and an inhalation passage495. A one-way valve 491 is adapted to mount to within the manifoldplate 493 adjacent to the exhalation passage 494 such that the one-wayvalve 491 opens in response to air exhaled into the first opening 412,and closes in response to air inhaled through the first opening 412. Aseparate one-way valve 492 is adapted to mount within the manifold pate493 adjacent to the inhalation passage 495 such that the one-way valve492 closes in response to air exhaled into the first opening 412, andopens in response to air inhaled through the first opening 412. Therespiratory treatment device 400 also includes a restrictor member 430and a vane 432 operatively connected by a shaft 434, the assembly ofwhich may operate in the same manner as described above with regards tothe disclosed OPEP devices.

Referring now to FIGS. 55 and 56, cross-sectional perspective views areshown taken along lines I and II, respectively, in FIG. 53. Therespiratory treatment device 400 administers oscillating pressuretherapy upon both inhalation and exhalation in a manner similar to thatshown and described above with regards to the OPEP devices. As describedin further detail below, the OPEP device 400 includes a plurality ofchambers (i.e., more than one). Air transmitted through the firstopening 412 of the housing 402, whether inhaled or exhaled, traverses aflow path that passes, at least in part, past a restrictor member 430housed in a first chamber 414, and through a second chamber 418 whichhouses a vane 432 operatively connected to the restrictor member 430. Inthis regard, at least a portion of the flow path for both air exhaledinto or inhaled from the first opening 412 is overlapping, and occurs inthe same direction.

For example, an exemplary flow path 481 is identified in FIGS. 55 and 56by a dashed line. Similar to the previously described OPEP devices, therestrictor member 430 is positioned in the first chamber 414 and ismovable relative to a chamber inlet 404 between a closed position, wherethe flow of air through the chamber inlet 404 is restricted, and an openposition, where the flow of air through the chamber 404 inlet is lessrestricted. After passing through the chamber inlet 404 and entering thefirst chamber 414, the exemplary flow path 481 makes a 180-degree turn,or reverses longitudinal directions (i.e., the flow path 481 is foldedupon itself), whereupon the exemplary flow path 481 passes through anorifice 438 and enters the second chamber 418. As with the previouslydescribed OPEP devices, the vane 432 is positioned in the second chamber418, and is configured to reciprocate between a first position and asecond position in response to an increased pressure adjacent the vane,which in turn causes the operatively connected restrictor member 430 torepeatedly move between the closed position and the open position.Depending on the position of the vane 432, air flowing along theexemplary flow path 481 is directed to one of either a first chamberoutlet 406 or a second chamber outlet 408. Consequently, as inhaled orexhaled air traverses the exemplary flow path 481, pressure at thechamber inlet 404 oscillates.

The oscillating pressure at the chamber inlet 404 is effectivelytransmitted back to a user of the respiratory treatment device 400,i.e., at the first opening 412, via a series of chambers. As seen inFIGS. 55 and 56, the respiratory treatment device includes a firstadditional chamber 496, a second additional chamber 497, and a thirdadditional chamber 498, which are described in further detail below.

The mouthpiece 409 and the first additional chamber 496 are incommunication via the first opening 412 in the housing 402. The firstadditional chamber 496 and the second additional chamber 497 areseparated by the manifold plate 493, and are in communication via theexhalation passage 494. The one-way valve 491 mounted adjacent to theexhalation passage 494 is configured to open in response to air exhaledinto the first opening 412, and close in response to air inhaled throughthe first opening 412.

The first additional chamber 496 and the third additional chamber 498are also separated by the manifold plate 493, and are in communicationvia the inhalation passage 495. The one-way valve 492 mounted adjacentto the inhalation passage 495 is configured to close in response to airexhaled into the first opening 412, and open in response to air inhaledthrough the first opening 412.

Air surrounding the respiratory treatment device 400 and the secondadditional chamber 497 are in communication via the third opening 415 inthe housing 402. The one-way valve 484 is configured to close inresponse to air exhaled in to the first opening 412, and open inresponse to air inhaled through the first opening 412.

Air surrounding the respiratory treatment device 400 and the thirdadditional chamber 498 are in communication via the second opening 413in the housing 402. The one way-valve 490 mounted adjacent the secondopening 413 is configured to open in response to air exhaled into thefirst opening 412, and close in response to air inhaled through thefirst opening 412. The third additional chamber 498 is also incommunication with the second chamber 418 via the first chamber outlet406 and the second chamber outlet 408.

Referring now to FIGS. 57-58, cross-sectional perspective views takenalong lines I and II, respectively, of FIG. 53, illustrate an exemplaryexhalation flow path 410 formed between the first opening 412, or themouthpiece 409, and the second opening 413. In general, upon exhalationby a user into the first opening 412 of the housing 402, pressure buildsin the first additional chamber 496, causing the one-way valve 491 toopen, and the one-way valve 492 to close. Exhaled air then enters thesecond additional chamber 497 through the exhalation passage 494 andpressure builds in the second additional chamber 497, causing theone-way valve 484 to close and the restrictor member 430 to open. Theexhaled air then enters the first chamber 414 through the chamber inlet404, reverses longitudinal directions, and accelerates through theorifice 438 separating the first chamber 414 and the second chamber 418.Depending on the orientation of the vane 432, the exhaled air then exitsthe second chamber 418 through one of either the first chamber outlet406 or the second chamber outlet 408, whereupon it enters the thirdadditional chamber 498. As pressure builds in the third additionalchamber 498, the one-way valve 490 opens, permitting exhaled air to exitthe housing 402 through the second opening 413. Once the flow of exhaledair along the exhalation flow path 410 is established, the vane 432reciprocates between a first position and a second position, which inturn causes the restrictor member 430 to move between the closedposition and the open position, as described above with regards to theOPEP devices. In this way, the respiratory treatment device 400 providesoscillating therapy upon exhalation.

Referring now to FIGS. 59-60, different cross-sectional perspectiveviews taken along lines I and II, respectively, of FIG. 53, illustratean exemplary inhalation flow path 499 formed between the third opening415 and the first opening 412, or the mouthpiece 409. In general, uponinhalation by a user through the first opening 412, pressure drops inthe first additional chamber 496, causing the one-way valve 491 toclose, and the one-way valve 492 to open. As air is inhaled from thethird additional chamber 498 into the first additional chamber 496through the inhalation passage 495, pressure in the third additionalchamber 498 begins to drop, causing the one-way valve 490 to close. Aspressure continues to drop in the third additional chamber 498, air isdrawn from the second chamber 418 through the first chamber outlet 406and the second chamber outlet 408. As air is drawn from the secondchamber 918, air is also drawn from the first chamber 414 through theorifice 438 connecting the second chamber 418 and the first chamber 414.As air is drawn from the first chamber 414, air is also drawn from thesecond additional chamber 497 through the chamber inlet 404, causing thepressure in the second additional chamber 497 to drop and the one-wayvalve 484 to open, thereby permitting air to enter the housing 402through third opening 415. Due to the pressure differential between thefirst additional chamber 496 and the second additional chamber 497, theone-way valve 491 remains closed. Once the flow of inhaled air along theinhalation flow path 499 is established, the vane 432 reciprocatesbetween a first position and a second position, which in turn causes therestrictor member 430 to move between the closed position and the openposition, as described above with regards to the OPEP devices. In thisway, the respiratory treatment device 400 provides oscillating therapyupon inhalation.

Fifth Embodiment

Turning to FIGS. 61-66, another embodiment of a respiratory treatmentdevice 500 is shown. Like the respiratory treatment device 400, therespiratory treatment device 500 is configured to provide OPEP therapyupon both exhalation and inhalation. Except as described below, thecomponents and configuration of the OPEP device 400 are the same as orsimilar to that of the respiratory treatment device 400.

The respiratory treatment device 500 differs from the respiratorytreatment device 400 in that it is configured to selectively provideOPEP therapy upon exhalation only, inhalation only, or both exhalationand inhalation. As explained in greater detail below, a user may selectadministration of OPEP therapy upon exhalation only, inhalation only, orboth exhalation and inhalation, by operation of a switch 504. Thoseskilled in the art will appreciate that the concepts described belowwith regards to the respiratory treatment device 500 may be applied toany of the previously described embodiments.

FIGS. 61 and 62 are front and rear perspective views of the respiratorytreatment device 500. FIG. 63A is a front perspective view of therespiratory treatment device 500 shown without the switch 504, whereasFIG. 63B is a rear perspective view of the respiratory treatment device500 shown without a valve mechanism 550, described below. In general,the respiratory treatment device 500 includes a housing 502 having afont section 501, a middle section 503, and a rear section 505. Like therespiratory treatment device 400, the housing 502 is openable so thanthe contents of the hosing 502 may be accessed for cleaning and/orselective replacement or adjustment of the components contained therein.

Like the respiratory treatment device 400, as seen in FIG. 63B, thehousing 502 includes a first opening 512, a second opening 513, and athird opening 515. As seen in FIG. 63A, the housing 502 of therespiratory treatment device 500 further includes a fourth opening 516,and a fifth opening 517. The valve mechanism 550 is similar to theone-way exhalation valve 490 and the one-way inhalation valve 484 of therespiratory treatment device 400 in that the valve mechanism 550comprises a one-way exhalation valve member 590 and a one-way inhalationvalve member 584 formed together to respectively permit air to exit thehousing 502 through the second opening 513 upon exhalation at the firstopening 512, and permit air to enter the housing 502 through the thirdopening 515 upon inhalation at the first opening 512.

Although the first opening 512 is shown as being associated with amouthpiece 509, the first opening 512 may be associated with other userinterfaces. Additionally, as seen in FIGS. 61-62, the mouthpieces 509may comprise a control port 580 equipped with a regulation member 579configured to permit a user to selectively adjust the amount of exhaledor inhaled air allowed to pass through the control port 580. As shown inFIGS. 61-62, the regulation member 579 is formed as a ring configured torotate relative to the mouthpiece 509 to either increase or decrease thecross-sectional area of the control port 579 through which air may flow.By selectively increasing the cross-sectional area of the control port580 through which air may flow, a user may decrease the amplitude andfrequency of the OPEP therapy administered by the respiratory treatmentdevice 500, and vice-versa. In this way, a user may selectively adjustthe respiratory treatment device 500 to maintain the ideal operatingconditions.

Turning to FIG. 64A-C, front views of the respiratory treatment device500 are shown, illustrating the positioning of the switch 504 relativeto the fourth opening 516 and the fifth opening 517 to selectivelycontrol administration of OPEP therapy upon exhalation only, inhalationonly, or both exhalation and inhalation. If the switch 504 is in amiddle position, as shown in FIG. 64A, both the fourth opening 516 andthe fifth opening 517 are blocked, such that the respiratory treatmentdevice 500 will provide OPEP therapy upon both exhalation andinhalation. With the switch 504 in the middle position, the respiratorytreatment device 500 operates as shown in FIGS. 57-60 and describedabove with regards to the respiratory treatment device 400.

With the switch 504 moved to a left position, as shown in FIG. 64B, thefourth opening 516 is closed while the fifth opening 517 remains open,such that the respiratory treatment device 500 will provide OPEP therapyupon exhalation in a manner similar to that of the respiratory treatmentdevice 400 shown in FIGS. 57-58. Upon inhalation, air is drawn into thehousing 502 through the fifth opening 517, as shown in thecross-sectional view of FIG. 65. The inhaled air then follows aninhalation flow path 518, as represented by a solid line, between thefifth opening 517 and the mouthpiece 509 associated with the firstopening 512. In comparison, when the switch 504 is in the middleposition, inhaled air is drawn into the housing 502 through the thirdopening 515, and follows an inhalation flow path 519 represented, inpart, by a dashed line, similar to that of the inhalation flow path 499of the respiratory treatment device 400 shown in FIGS. 59-60.

If the switch 504 is moved to a right position, as shown in FIG. 64C,the fourth opening 516 remains open, such that the respiratory treatmentdevice 500 will provide OPEP therapy upon inhalation in a manner similarto that of the respiratory treatment device 400 shown in FIGS. 59-60.Upon exhalation, air exits the housing 502 through the fourth opening516, as shown in the cross-sectional view of FIG. 66. The exhaled airfollows an exhalation flow path 510, as represented by a solid line,between the mouthpiece 509 associated with the first opening 512 and thefourth opening 516. In comparison, when the switch 504 is in the middleposition, exhaled air follows an exhalation flow path 511 represented,in part, by a dashed line, similar to that of the exhalation flow path410 of the respiratory treatment device 400 shown in FIGS. 57-58.

Sixth Embodiment

Turning to FIGS. 67-70, another embodiment of a respiratory treatmentdevice 600 is shown. As explained below, the respiratory treatmentdevice 600 is configured to provide pressure threshold therapy in serieswith OPEP therapy. Although the respiratory treatment device 600 isshown an described as delivering pressure threshold therapy in serieswith OPEP therapy upon inhalation, it is envisioned that the respiratorytreatment device 600 could also be configured for delivery of pressurethreshold therapy in series with OPEP therapy upon exhalation.

In general, the respiratory treatment device 600 provides OPEP therapyin a manner similar to the other embodiments described herein. Therespiratory treatment device includes a housing 601 enclosing aninhalation portal 602 and a mouthpiece 603. An inhalation flow path 604is defined through the housing 601 between the inhalation portal 602 andthe mouthpiece 603, as represented by a dashed line. The inhalation flowpath 604 beings at the inhalation portal 602, passes into a firstchamber 605, then into a second chamber 606, before exiting the housing601 through the mouthpiece 603. Separating the inhalation portal 602 andthe mouthpiece is a wall 610. Separating the inhalation portal 602 andthe first chamber 605 is a restrictor member 609. Separating the firstchamber 605 and the second chamber 606 is an orifice 607. The restrictormember 609 is operatively connected to a vane 608 disposed in the secondchamber 606, such that rotation of the vane 608 results in rotation ofthe restrictor member 609. Similar to the administration of OPEP therapydescribed above with regards to the previous embodiments, as air flowsalong the inhalation flow path 604, the vane 608, and therefore therestrictor member 609, reciprocate between a first position, where therestrictor member 609 is closed, and a second position, where therestrictor member 609 is open, thereby creating an oscillating pressureat the mouthpiece 603.

In addition the respiratory treatment device 600 may include a pressurethreshold valve 611 disposed in the respiratory portal 602. The pressurethreshold valve 611 may be any type of suitable valve configured toremain closed until a given negative pressure is obtained in theinhalation portal 602. In this way, the respiratory treatment device 600also provides pressure threshold therapy in series with OPEP therapy.For example, as a user inhales at the mouthpiece 603, pressure decreasesin the mouthpiece 603, which causes pressure to decrease in the secondchamber 606, which causes pressure to decrease in the first chamber 605,which causes pressure to drop in the inhalation port 602. Once thethreshold pressure is reached in the inhalation portal 602, the pressurethreshold valve 611 opens, allowing air to enter the housing 601 throughthe inhalation portal 602. As air enters the housing 601 through theinhalation portal 602, it is drawn along the inhalation flow path 604,resulting in the administration of OPEP therapy.

Seventh Embodiment

Turning to FIGS. 71-75, another embodiment of a respiratory treatment700 device is shown. As explained below, the respiratory treatmentdevice 700 is configured to provide pressure threshold therapy inparallel with OPEP therapy. Although the respiratory treatment device700 is shown an described as delivering pressure threshold therapy inparallel with OPEP therapy upon inhalation, it is envisioned that therespiratory treatment device 700 could also be configured for deliveryof pressure threshold therapy in parallel with OPEP therapy uponexhalation.

In general, the respiratory treatment device 700 provides OPEP therapyin a manner similar to the other embodiments described herein. Therespiratory treatment device includes a housing 701 enclosing aninhalation portal 702 and a mouthpiece 703. The housing 701 alsocomprises one or more inhalation openings 711. An inhalation flow path704 is defined through the housing 701 between the inhalation openings711 and the mouthpiece 703, as represented by a dotted line. Theinhalation flow path 704 beings at the inhalation openings 711, passesinto a first chamber 705, then into a second chamber 706, before exitingthe housing 701 through the mouthpiece 703. Separating the inhalationportal 602 and the inhalation openings 711 is a wall 710. Separating theinhalation openings 711 and the first chamber 705 is a restrictor member709. Separating the first chamber 705 and the second chamber 706 is anorifice 707. The restrictor member 709 is operatively connected to avane 708 disposed in the second chamber 706, such that rotation of thevane 708 results in rotation of the restrictor member 709. Similar tothe administration of OPEP therapy described above with regards to theprevious embodiments, as air flows along the inhalation flow path 704,the vane 708, and therefore the restrictor member 709, reciprocatebetween a first position, where the restrictor member 709 is closed, anda second position, where the restrictor member 709 is open, therebycreating an oscillating pressure at the mouthpiece 703. In addition therespiratory treatment device 700 may include a pressure threshold valve711 disposed in the respiratory portal 702. The pressure threshold valve711 may be any type of suitable valve configured to remain closed untila given negative pressure is obtained in the inhalation portal 702. Inthis way, the respiratory treatment device 700 also provides pressurethreshold therapy in parallel with OPEP therapy. For example, as a userinhales at the mouthpiece 703, pressure decreases in the mouthpiece 703and in the inhalation portal 702, which causes pressure to decrease inthe second chamber 706, which causes pressure to decrease in the firstchamber 705, which causes air to be drawn into the housing 701 throughthe inhalation openings 711. As air enters the housing 701 through theinhalation openings 711, it is drawn along the inhalation flow path 704for the administration of OPEP therapy. Additionally, if the thresholdpressure is reached in the inhalation portal 702, the pressure thresholdvalve 711 opens, allowing air to enter the housing 701 through theinhalation portal 702. As air enters the housing 701 through theinhalation portal 702, it is drawn along a second inhalation flow path712, as represented by a dashed line.

No Torque Scenarios

A “no torque scenario” in the operation of the embodiments describedherein, along with means for reducing the probability of a no torquescenario, will now be described. Although the following descriptions ofmeans for reducing the probability of a no torque scenario are providedwith regards to the OPEP device 300 of FIG. 35, it should be appreciatedthat a no torque scenario may occur in any of the previously describedembodiments, and that the means for reducing the probability of a notorque scenario described below may be utilized in any such devices.Likewise, it should be appreciated that the means described below forreducing the probability of a no torque scenario may be utilized inother respiratory treatment devices, such as those shown and describedin U.S. patent application Ser. No. 13/489,984, filed on May 6, 2012,which is incorporated herein by reference.

A no torque scenario occurs in the previously described embodiments whenthe net torque being applied to the restrictor member and the vane, forexample, at the start of exhalation, is zero. In such a scenario, therestrictor member and the vane do not rotate, and OPEP therapy is notadministered. As used herein, torque is defined as the tendency of aforce to rotate an object about an axis, fulcrum, or pivot and can beeither positive or negative depending on the direction of rotation. Forpurposes of the following description, a positive torque is defined asone that opens the restrictor member 330 and a negative torque is onethat closes the restrictor member 330. As previously explained, torquesact on both the restrictor member 330 and the vane 332 and are createdfrom the pressure and flow of exhaled air along the exhalation flow path310. The torque that acts on the restrictor member 330 is alwayspositive, whereas the torque that acts on the vane 332 is eitherpositive or negative, depending on the position of the vane 332. As usedherein, net torque is defined as the sum of all torques acting on therestrictor member 330 and the vane 332.

Turning to FIG. 76, an exemplary illustration is provided showing thenet torque about the restrictor member 330 and the vane 330 of the OPEPdevice 300 as the restrictor member 330 rotates from a closed positionto an open position during a period of exhalation. The net torques shownin FIG. 76 are provided solely by way of example, and represent only onepossible set of operating characteristics for the OPEP device 300. Fourpoints of interest during the rotation of the restrictor member 330identified in FIG. 76 are discussed below.

At the first point of interest, or 0° rotation, the restrictor member330 is completely closed and no air is permitted to flow past therestrictor member 330 into the first chamber 314 during a period ofexhalation. The relative positions of the restrictor member 330 and thevane 332, at that point, are shown in FIGS. 77A and 77B. In thosepositions, the torque on the vane 332 is zero and the torque on therestrictor member 330 is dependent on the pressure generated by theuser.

At the second point of interest, the restrictor member 330 begins toopen, for example, due to the pressure generated by a user exhaling intothe OPEP device 300, and air is permitted to flow past the restrictormember 330 into the first chamber 314. As the restrictor member 330opens, the torque acting on the restrictor member 330 begins todecrease, while the torque acting on the vane 332 beings to increase. Atthat point, since the torque on the restrictor member 330 remainsdominant, the net torque acting on the restrictor member 330 and thevane 332 decreases.

At the third point of interest, the restrictor member 330 and the vane332 are in a position such that there is no net torque acting on therestrictor member 330 and the vane 332. The approximate positions of therestrictor member 330 and the vane 332, at that point, are respectivelyshown in FIGS. 77C and 77D. As shown in FIG. 77D, in this position, thevane 332 is nearly aligned with the orifice 338 of the variable nozzle336. If the restrictor member 330 and the vane 332 are at rest inapproximately those positions at the start of a period of exhalation,the resulting net torque may be zero. However, under normal operatingconditions, the restrictor member 330 and the vane 332 are not at rest,and there is enough momentum to rotate the restrictor member 330 and thevane 332 past that position for the continued administration of OPEPtherapy.

At the fourth point of interest, the restrictor member 330 has rotatedpast the “no torque position” described as the third point of interest,such that the net torque acting on the restrictor member 330 and thevane 332 is negative.

FIG. 78A is a cross-sectional view of the OPEP device 300 of FIG. 35illustrating a potential no torque scenario. As stated above, no torquescenario may occur when the vane 332 comes to rest in a position almostaligned with the orifice 338 of the variable nozzle 336. In the case ofsuch a scenario, a user could simply tap or shake the OPEP device 300until the vane 332 rotates out of the position shown in FIG. 78A.Alternatively, a user could open the housing 302 and rotate the vane 332out of the position shown in FIG. 78A.

In the position shown in FIG. 78A, the vane 332 may not rotate inresponse to a flow of exhaled air along the exhalation flow path 310, asthe air exiting the variable nozzle 336 through the orifice 338 is splitrelatively equally on both sides of the vane 332, as illustrated by thearrows shown in FIG. 78A, such that the net torque acting on therestrictor member 330 and the vane 332 is zero. In this position, thepressure on both sides of the vane 332 remains relatively equal, suchthat any torque about the vane 332 is offset by an opposing torque aboutthe restrictor member 330. As further illustrated in FIG. 78B, when thevane 332 is aligned with the variable nozzle 336, a torque continues toact on the restrictor member 330. Therefore, when the vane 332 is inline with the variable nozzle 336, the only torque acting on therestrictor member 330 and the vane 332 is an opening torque, T1. As thistorque begins to turn the restrictor member 330, and therefore the vane332, the leading edge of the vane 332 directs the air exiting thevariable nozzle 336 onto one side of the vane 332, as shown in FIG. 78C,thereby generating a negative torque, T2. When T1 equals T2, a no torquescenario may occur if the momentum of the restrictor member 330 and thevane 332 is not sufficient to continue rotating the restrictor member330 and the vane 332 past the no torque position.

As described herein, various approaches to reducing the probability of ano torque scenario include preventing the vane 332 from stopping in theno torque position, and forcing the vane 332 to move out of the notorque position. In one embodiment, shown in FIG. 78D, a modified vane333 is configured to reduce the probability of a no torque scenario. Inparticular, a peripheral portion 335 of the modified vane 333 is angledrelative to a central portion 337 of the modified vane 333. Thus, asshown in FIG. 78E, if the modified vane 333 comes to rest in a positionwhere the central portion 337 of the modified vane 333 is directlyin-line with the orifice 338 of the variable nozzle 336, the angledperipheral portion 335 of the modified vane 333 directs air exiting thevariable nozzle 336 through the orifice 338 onto one side of the vane333. Consequently, a high pressure is created on one side of the vane333, causing the vane 333 to rotate.

A further modification resulting from inclusion of the modified vane 333in the OPEP device 300 is illustrated in FIG. 78F. As a result of theangled peripheral portion 335 of the modified vane 333, the totalrotation of the modified vane 333, as compared to the unmodified vane332, is reduced. In particular, the peripheral portion 335 of themodified vane 333 contacts the walls of the second chamber 318 in anorientation with less rotation than that of the unmodified vane 332.Consequently, the restrictor member 330 (see FIGS. 38-40) may not fullyclose, thereby affecting performance of the OPEP device 300. In order toensure the restrictor member 330 fully closes, the angle of the centralportion 337 of the modified vane 333 relative to the restrictor member330 may be adjusted.

Likewise, the angled peripheral portions 335 also increase the amount ofrotation the restrictor member 330 and the modified vane 333 have tobuild up momentum in order to continue rotating past the no torqueposition. For example, in one embodiment, illustrated in FIGS. 78G-H,where the OPEP device 300 is configured for the high setting, and withthe restrictor member 330 completely closed, the vane 332 only provides6.5° of rotation, while the modified vane 333 provides 10.4°.

In another embodiment, as shown in FIGS. 79A-B, a weight 331 may beadded to the restrictor member 330 such that gravity prevents the vane332 from stopping in the no torque position. In the previously describeddesign, shown in FIG. 79A, the restrictor member 330 is balanced suchthat the center of mass is aligned with the axis of rotation and noadditional torque is created due to gravity. In the modified design,shown in FIG. 79B, the additional weight 331 moves the center of massoff of the axis of rotation. Thus, when the OPEP device 300 is held inthe vertical position, for example, the additional gravitational torqueacts to close the restrictor member 330 and move the vane 332 out of theno torque position. However, a consequence of the additional weight 331is that the performance characteristics of the OPEP device 300 areimpacted. Therefore, it is important to provide enough additional weight331 to move the restrictor mechanism 330 and the vane 332 out of the notorque position, but not so much weight that the performance of the OPEPdevice 300 suffers. In one embodiment, the ideal amount of additionalweight is 0.25 g.

In another embodiment, both of the previously described modificationsare utilized, as illustrated in FIGS. 80A-B. In this embodiment, aweight 331 is added to the restrictor member 330, and a peripheralportion 335 of a modified vane 333 is angled relative to a centralportion 337. In this way, the modified vane 333 leads to a positivetorque, T2, acting on the modified vane 333, such that T1 and T2 worktogether, rather than cancelling each other out.

In another embodiment, as shown in FIG. 81, an additional weight 339 isadded to the restrictor member 330 on the side opposite of theadditional weight 331 of the restrictor member 330 shown in FIG. 79B.The additional weight 339 serves to create a positive torque that worksto open the restrictor member 330. One benefit of the of this embodimentis that the amount of rotation the restrictor member 330 and the vane332 have to build up momentum in order to rotate past the no torqueposition is greater from the fully open position. At low flow rates,however, the performance of the OPEP device 300 may be impacted.

In an alternative embodiment, as shown in FIGS. 82A-C, an elastic band341 is attached to the vane 332 on the central portion 337 of the vane332 opposite of the variable nozzle 336. As seen in FIGS. 82A and 82C,when the vane 332 is rotated to the positions shown, the elastic band341 is not under tension. As seen in FIG. 82B, when the vane rotatestoward the position shown, the elastic band 341 is under tension andbiases the vane 332 toward one of the positions shown in FIG. 82A or82B.

In yet another embodiment, shown in FIGS. 83A-83B, air flow is used torotate the vane 332 out of the no torque position. At the start ofexhalation, as illustrated in FIG. 83A, air flow passes by therestrictor member 330 into the first chamber 314. In the first chamber314, a shuttle valve 342 obstructs the exhalation flow path 310. Theshuttle valve 342 may be biased, for example, by a spring (not shown)tuned to open and close at desired pressures. With the shuttle valve inthis position, the exhaled air is permitted to exit the first chamber314 through an exit port 343. The flow of exhaled air past therestrictor member 330 and out the exit port 343 may therefore rotate therestrictor member 330 and the vane 332 out of a no torque position.Then, as illustrated in FIG. 83B, at a given pressure, the shuttle valve342 opens and allows the flow of exhaled air to traverse the exhalationflow path 310 for the administration of OPEP therapy. As the shuttlevalve 342 opens the flow of exhaled air along the exhalation flow path310, the shuttle valve 342 also closes the exit port 343 to maintain theideal operating characteristics.

In another embodiment, shown in FIGS. 84A-B, airflow is used to move therestrictor member 330 and the vane 332 out of the no torque position. Atop view of the restrictor member 330 is shown in FIG. 84A-B. As shownin FIG. 84A, in the no torque position, exhaled air can flow past therestrictor member 330 on both sides. The opening torque, T1 (referred toabove), is the sum of all the torque acting on the restrictor member330. As shown in FIG. 84B, a diverter may be added upstream of therestrictor member 330 to direct all flow of exhaled air onto one side ofthe restrictor member 330, thereby increasing the opening torque. Alarger opening torque will provide more momentum at startup andtherefore lower the chance of a no torque scenario.

In a different embodiment, shown in FIG. 85A-C, inhaled air is used tomove the restrictor member 330 and the vane 332 out of a no torqueposition. As previously described, the OPEP device 300 includes aninhalation port 311 comprising a one-way valve 384 configured to openupon inhalation. In this embodiment, shown in FIGS. 85A-B, a secondone-way valve 383 is added to the OPEP device 300 so that air can flowpast the restrictor member 330 during inhalation. Normally, air cannotflow past the restrictor member 330 during inhalation because thevariable nozzle 336 closes. In this embodiment, the flow of air past therestrictor member 330 upon inhalation creates a torque that moves therestrictor member 330 and the vane 332 out of the no torque position.Upon exhalation, shown in FIG. 85C, both inhalation valves 383 and 384close and the OPEP device 300 functions as normal.

In yet another embodiment, shown in FIGS. 86A-C, air flow at the leadingedge of the vane 332 is used to move the vane 332 and the restrictormember 330 out of the no torque position. As shown in FIG. 86A, aflexible tip 347 may added to the end of the vane 332 that, in the notorque position, flexes and/or vibrates as air exits the variable nozzle336. The flexible tip 347 may be formed of any suitable elasticmaterial. As the flexible tip 347 flexes and/or vibrates, the vane 332is urged out of the no torque position. The flexible tip 347 may alsocomprise one or more hinge points 349. If the flexible tip 347 includeshinge points 349 on both sides of the flexible tip 347, as shown in FIG.86B, the flexible tip will flex in both directions. If the flexible tip347 includes a hinge point 349 on only one side of the flexible tip 347,as shown in FIG. 86C, the flexible tip will flex only in that direction,thus resulting in an angled peripheral portion of the vane 332, similarto the modified vane 333 described above.

Those skilled in the art will appreciated that the various conceptsdescribed above with regards to a particular embodiment of a respiratorytreatment device may also be applied to any of the other embodimentsdescribed herein, even though not specifically shown or described withregards to the other embodiments. For example, any one of theembodiments described herein may include a variable nozzle, aninhalation port adapted for use with an aerosol delivery device for theadministration of aerosol therapy, an adjustment mechanism for adjustingthe relative position of the chamber inlet and/or the permissible rangeof movement by a restrictor member, means for reducing the probabilityof a no torque scenario, etc.

Although the foregoing description is provided in the context of OPEPdevices, it will also be apparent to those skilled in the art will thatany respiratory device may benefit from various teachings containedherein. The foregoing description has been presented for purposes ofillustration and description, and is not intended to be exhaustive or tolimit the inventions to the precise forms disclosed. It will be apparentto those skilled in the art that the present inventions are susceptibleof many variations and modifications coming within the scope of thefollowing claims.

Exemplary Implementations

In one implementation, a respiratory treatment device includes aplurality of chambers, a first opening in the housing configured totransmit air exhaled into and air inhaled form the housing, a secondopening in the hosing configured to permit air exhaled into the firstopening to exit the housing, and a third opening in the housingconfigured to permit air outside the housing to enter the housing uponinhalation at the first opening. An exhalation flow path is definedbetween the first opening and the second opening, and an inhalation flowpath is defined between the third opening and the first opening. Arestrictor member is positioned in the exhalation flow path and theinhalation flow path, such that the restrictor member is movable betweena closed position, where a flow of air along the exhalation flow path orthe inhalation flow path is restricted, and an open position, where theflow of exhaled air along the exhalation flow path or the inhalationflow path is less restricted. A vane is in fluid communication with theexhalation flow path and the inhalation flow path, the vane beingoperatively connected to the restrictor member and configured torepeatedly reciprocate between a first position and a second position inresponse to the flow of air along the exhalation flow path or theinhalation flow path. A fourth opening in the housing is configured topermit the flow of air along the exhalation flow path to exit thehousing prior to the position of the restrictor member in the exhalationflow path. A fifth opening in the housing is configured to permit airoutside the housing to enter the inhalation flow path upon inhalation atthe first opening subsequent to the position of the restrictor member inthe inhalation flow path. A switch is positioned relative to the fourthopening and the fifth opening such that one or both of the fourthopening and the fifth opening may be closed by the switch.

The respiratory treatment device may be configured to provide OPEPtherapy upon both inhalation and exhalation when the switch ispositioned relative to the fourth opening and the fifth opening suchthat both of the fourth opening and the fifth opening are closed by theswitch. The respiratory treatment device may be configured to provideOPEP therapy upon exhalation when the switch is positioned relative tothe fourth opening such that the fourth opening is closed by the switch.The respiratory treatment device may be configured to provide OPEPtherapy upon inhalation when the switch is positioned relative to thefifth opening such that the fifth opening is closed by the switch.

The exhalation flow path and the inhalation flow path may form anoverlapping portion. The flow of air along the exhalation flow path andthe inhalation flow path along the overlapping portion may be in thesame direction. The restrictor member may be positioned in theoverlapping portion, while the vane may be in fluid communication withthe overlapping portion. The restrictor member may be positioned in afirst chamber of the plurality of chambers, while the vane may bepositioned in a second chamber of the plurality of chambers. The flow ofair through an inlet to the first chamber may be restricted when therestrictor member is in the closed position, while the flow of airthrough the inlet may be less restricted when the restrictor member isin the open position. The first chamber and the second chamber may beconnected by an orifice. The vane may be positioned adjacent theorifice, the vane being configured to move the restrictor member betweenthe closed position and the open position in response to an increasedpressure adjacent the vane.

The second opening may include a one-way exhalation valve configured topermit air exhaled into the housing to exit the housing upon exhalationat the first opening. The third opening may include a one-way inhalationvalve configured to permit air outside the housing to enter the housingupon inhalation at the first opening. A one-way valve may be positionedalong the exhalation flow path between the first opening and the secondopening, the one-way valve being configured to open in response to airexhaled into the first opening, and close in response to air inhaledthrough the first opening. A one-way valve may be positioned along theinhalation flow path between the third opening and the first opening,the one-way valve being configured to open in response to air inhaledthrough the first opening, and close in response to air exhaled into thefirst opening.

An inhalation port may be in fluid communication with a user interface,wherein the inhalation port is adapted to receive an aerosol medicamentfrom an aerosol delivery device. The aerosol delivery device may beconnected to the inhalation port.

In another implementation, a respiratory treatment device includes ahousing enclosing at least one chamber, a chamber outlet configured topermit air in the housing to exit the housing, and a chamber inletconfigured to permit air outside the housing to enter the housing. Aflow path is defined between the chamber inlet and the chamber outlet. Arestrictor member is positioned in the flow path, the restrictor memberbeing moveable between a closed position, where a flow of air along theflow path is restricted, and an open position, where the flow of airalong the flow path is less restricted. A vane is in fluid communicationwith the flow path, the vane being operatively connected to therestrictor member and configured to reciprocate between a first positionand a second position in response to a flow of air along the flow path.A one-way valve is positioned in one of the chamber inlet or the chamberoutlet and is configured to close the one of the chamber inlet or thechamber outlet until a threshold pressure is obtained. The respiratorytreatment device may be configured to provide OPEP therapy in serieswith pressure-threshold therapy.

In another implementation, a respiratory treatment device includes ahousing enclosing at least one chamber, a chamber outlet configured topermit air in the housing to exit the housing, and a chamber inletconfigured to permit air outside the housing to enter the housing. Aflow path is defined between the chamber inlet and the chamber outlet. Arestrictor member is positioned in the flow path, the restrictor memberbeing moveable between a closed position, where a flow of air along theflow path is restricted, and an open position, where the flow of airalong the flow path is less restricted. A vane is in fluid communicationwith the flow path, the vane being operatively connected to therestrictor member and configured to reciprocate between a first positionand a second position in response to a flow of air along the flow path.A one-way valve is positioned in an opening and is configured to closethe opening until a threshold pressure is obtained. The respiratorytreatment device may be configured to provide OPEP therapy in parallelwith pressure-threshold therapy.

In another implementation, a respiratory treatment device includes ahousing enclosing at least one chamber, a chamber inlet configured toreceive exhaled air into the at least one chamber, and a chamber outletconfigured to permit exhaled air to exit the at least one chamber. Anexhalation flow path is defined between the chamber inlet and thechamber outlet. A restrictor member is positioned in the exhalation flowpath, the restrictor member being moveable between a closed position,where a flow of air along the exhalation flow path is restricted, and anopen position, where the flow of air along the exhalation flow path isless restricted. A vane is in fluid communication with the exhalationflow path, the vane being operatively connected to the restrictor memberand configured to reciprocate between a first position and a secondposition in response to a flow of air along the exhalation flow path. Ashuttle valve is positioned in the exhalation flow in a position betweenthe restrictor member and the vane, the shuttle valve being configuredto move in response to a threshold pressure obtained at the chamberinlet from a first position, where the flow of air along the exhalationflow path is diverted to an exit port, and a second position, where theflow of air along the exhalation flow path past the shuttle valve ispermitted.

In another implementation, a respiratory treatment device includes ahousing enclosing at least one chamber, a chamber inlet configured toreceive exhaled air into the at least one chamber, and a chamber outletconfigured to permit exhaled air to exit the at least one chamber. Anexhalation flow path is defined between the chamber inlet and thechamber outlet. A restrictor member is positioned in the exhalation flowpath, the restrictor member being moveable between a closed position,where a flow of air along the exhalation flow path is restricted, and anopen position, where the flow of air along the exhalation flow path isless restricted. A vane is in fluid communication with the exhalationflow path, the vane being operatively connected to the restrictor memberand configured to reciprocate between a first position and a secondposition in response to a flow of air along the exhalation flow path. Aone-way inhalation valve is positioned along the exhalation flow path ina position between the restrictor member and the vane, and is configuredto open once a threshold pressure is obtained upon inhalation at thechamber inlet.

What is claimed is:
 1. A respiratory treatment device comprising: ahousing enclosing at least one chamber; a chamber inlet configured toreceive air into the at least one chamber; at least one chamber outletconfigured to permit air to exit the at least one chamber; a flow pathdefined between the chamber inlet and the at least one chamber outlet;an orifice positioned in the at least one chamber along the flow pathsuch that the flow path passes through the orifice, and, a vanepositioned adjacent the orifice, the vane being configured to rotate inresponse to the flow of air through the orifice; wherein a peripheralportion of the vane is angled relative to a central portion of the vaneto direct substantially all the flow of air through the orifice to aside of the vane when the central portion of the vane is substantiallyaligned with the orifice.
 2. The respiratory treatment device of claim1, wherein the central portion of the vane is substantially planar. 3.The respiratory treatment device of claim 1, further comprising arestrictor member operatively connected to the vane, the restrictormember being configured to rotate between a closed position, where theflow of air along the flow path is restricted, and an open position,where the flow of air along the flow path is less restricted.
 4. Therespiratory treatment device of claim 3, wherein the restrictor memberand the vane are operatively connected by a shaft.
 5. The respiratorytreatment device of claim 4, wherein the restrictor member has a centerof mass offset from an axis of rotation of the shaft.
 6. The respiratorytreatment device of claim 5, wherein a force of gravity biases therestrictor member and the vane toward a position where the centralportion of the vane is not aligned with the orifice.
 7. A respiratorytreatment device comprising: a housing enclosing at least one chamber; achamber inlet configured to receive air into the at least one chamber;at least one chamber outlet configured to permit air to exit the atleast one chamber; a flow path defined between the chamber inlet and theat least one chamber outlet; an orifice positioned in the at least onechamber along the flow path such that the flow path passes through theorifice, and, a vane positioned adjacent the orifice, the vane beingconfigured to rotate in response to the flow of air through the orifice;wherein a peripheral portion of the vane is configured to flex relativeto a central portion of the vane in response to the flow of air throughthe orifice.
 8. The respiratory treatment device of claim 7, wherein thevane is substantially planar.
 9. The respiratory treatment device ofclaim 7, wherein a flexibility of the peripheral portion of the vane isgreater than a flexibility of the central portion of the vane.
 10. Therespiratory treatment device of claim 7, wherein the peripheral portionof the vane and the central portion of the vane are separated by atleast one hinge point.
 11. The respiratory treatment device of claim 10,wherein the at least one hinge point comprises a channel.
 12. Therespiratory treatment device of claim 7, further comprising a restrictormember operatively connected to the vane, the restrictor member beingconfigured to rotate between a closed position, where the flow of airalong the flow path is restricted, and an open position, where the flowof air along the flow path is less restricted.
 13. A respiratorytreatment device comprising: a housing enclosing at least one chamber; achamber inlet configured to receive air into the at least one chamber;at least one chamber outlet configured to permit air to exit the atleast one chamber; a flow path defined between the chamber inlet and theat least one chamber outlet; an orifice positioned in the at least onechamber along the flow path such that the flow path passes through theorifice, and, a vane positioned adjacent the orifice, the vane beingconfigured to rotate in response to the flow of air through the orifice;wherein the vane is biased toward a position where a central portion ofthe vane is not aligned with the orifice.
 14. The respiratory treatmentdevice of claim 13, wherein the vane is substantially planar.
 15. Therespiratory treatment device of claim 13, wherein the vane is biased byan elastic band.
 16. The respiratory tournament device of claim 15,where an end of the elastic band is attached to a side of the vaneopposite the side of the vane adjacent the orifice.
 17. The respiratorytreatment device of claim 13, further comprising a restrictor memberoperatively connected to the vane, the restrictor member beingconfigured to rotate between a closed position, where the flow of airalong the flow path is restricted, and an open position, where the flowof air along the flow path is less restricted.
 18. The respiratorytreatment device of claim 17, wherein the restrictor member and the vaneare operatively connected by a shaft.
 19. The respiratory treatmentdevice of claim 18, wherein the restrictor member has a center of massoffset from an axis of rotation of the shaft.
 20. The respiratorytreatment device of claim 19, wherein a force of gravity biases therestrictor member and the vane toward the position where the centralportion of the vane is not aligned with the orifice.